Regulatory Director Resume Sample
Nettie Kerluke
98597 Stark Place,
Chicago,
IL
+1 (555) 645 8401
Work Experience
Director Head of GMO Regulatory & Accounting Controls
09/2017
-
PRESENT
Detroit, MI
- A fundamental requirement within the firmwide Global Technology Controls Office function is the ability to operate as a team and in partnership
- Change Mgmt: Responsible for leading change Mgmt efforts for functional areas across the enterprise. Identifies and acts upon opportunities to leverage direct reporting team in change Mgmt activities; ensures direct reporting team is engaged in change Mgmt as appropriate
- Experience Required: 10+ years in surveillance, compliance or a regulatory role
- Prior management and demonstrated leadership experience is required
- Leadership - As a key Global Category Management leader of Regulatory & Clinical Safety R&D spend area, responsible to develop then implement sourcing strategy and ensure alignment, compliance and delivery of required business performance
- Procurement Leadership - Provide the leadership, strategy and policy oversight for the function building a high performance engagement model with the business and regions. Ensure that the team is focused and aligned to support Merck global procurement strategy and Global Category Management Ways of Working
- Organizational Development – Manage a core team of high quality procurement professionals who have direct responsibility for sourcing and projects. Responsibility includes effective talent management, building proactive recruitment bench & succession planning as key deliverables
- Performance - Deliver critical functional business objectives as well as meeting the stakeholder business requirements. Closely work with clinical operations stakeholders and CROs to ensure effective KPIs are implemented including quality & compliance categories
Director, Government & Regulatory Affairs
04/2011
-
07/2017
Houston, TX
- Proactive Cost Management: Achieves cost control, cost reduction, and cost containment targets, and adds value to area of category expenditure through a strong total cost orientation
- Change Management - Adopt high quality change practices with customers and stakeholders, building and implementing an organization which is sustainable. Be a personal exemplar of the Merck Leadership Standards
- Supplier Value Management - Implements Supplier Value Management with the key suppliers in this category to foster innovation, manage supplier performance, establish a Governance Model, and ensure continuous improvement
- Serves as the US and global regulatory strategy lead for assigned projects. Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Proactively identifies and assesses regulatory risks associated with product development for assigned projects
- Leads Global Regulatory Team and represents regulatory affairs function on key internal program teams
- Coordinates cross-functional group of regulatory professionals as part of Global Regulatory Team, including CMC, Operations, Labeling, International, Advertising/Promotion and RA Intel/Policy to drive global regulatory strategies
- Leads the development of strategic plans and tactical implementation for the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings
- Designs and implements US regulatory strategies to obtain and maintain INDs and NDAs/BLAs, and to extend product registrations
Regulatory Director
02/2006
-
10/2010
San Francisco, CA
- Serves as corporate liaison to FDA to develop effective professional relationships as well as positive company image
- Effectively leads key meetings with US and international HAs to ensure full discussion of issues and opportunities
- Ensures IA meets/exceeds the requirements and expectations of Citibank’s and Citigroup's regulators
- Specific subject matter expertise regarding understanding of Markets products
- Improve internal processes for management of Regulatory & Audit engagements, ensuring controlled, consistent responses and ability to meet regulatory requirements
- Work with Firmwide Cybersecurity colleagues and other internal teams, including but not limited to Legal, Compliance, Oversight & Control and management teams
- Providing thought leadership to Firm Management, business units and infrastructure areas regarding MS EMEA regulatory relationships and related developments
- Managing and overseeing the Firm’s interactions with its Regulators in EMEA
- Managing the Firm’s responsiveness to its Regulators including facilitating understanding and clarification of regulatory messages
Education
Western International University
2002 - 2006
Bachelor's Degree in Accounting
Professional Skills
- Development of client-focused solutions based on understanding strategy, operations and management in a number of functional areas of corporations and organizations
- Excellent communications and problem solving skills
- Proven record of acquiring and managing engagements within a top tier consulting firm effectively integrating the areas of governance, risk and compliance
- Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams
- Strategic Influencing -- through well thought out rationale and effective communication skills, able to influence key decisions
- Demonstrated knowledge of / or experience with the broader Canadian financial sector, regulatory affairs or legal issues
- Demonstrates strong awareness of business and organization sensitivity and adapts communication accordingly
How to write Regulatory Director Resume
Regulatory Director role is responsible for communications, compensation, finance, training, integration, database, procurement, auditing, litigation, reporting.
To write great resume for regulatory director job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Director Resume
The section contact information is important in your regulatory director resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Regulatory Director Resume
The section work experience is an essential part of your regulatory director resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous regulatory director responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory director position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Director resume experience can include:
- Experience in Audit, Banking and other professional services regulators, preferably in the region
- Responsible for entering and tracking of formal remediation actions in the Firm’s regulatory issues tracking system (OpenPages)
- Take a lead role in the Firm’s communication with regulators regarding risk management related issues
- Work autonomously, capable of day-to-day management of people and projects, think strategically and participate in long-term planning efforts
- Able to manage within budgetary and time constraints while providing a high-level of client satisfaction
- Responsible for the development and motivation of engagement staff and provide them with leadership, counseling and career guidance
Education on a Regulatory Director Resume
Make sure to make education a priority on your regulatory director resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory director experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Regulatory Director Resume
When listing skills on your regulatory director resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical regulatory director skills:
- Optimal position to learn and understand the perspectives of key stakeholders (both internal: R&D, Marketing, Legal, etc. and external: regulatory and public health authorities, scientific community)
- Demonstrated ability with complex problem solving and, excellent written and verbal communications is required
- Capable of effectively communicating with internal leaders, and relevant stakeholders to keep all parties informed of regulatory changes in the Middle East
- Demonstrated experience leading successful 510K and/or PMA submissions through the FDA
- Experience managing staff across multiple regions, including performance management, succession planning, utilization, and allocation
- Experience building out conduct risk programs and development of KRI’s/KPI’s and MI reporting
List of Typical Experience For a Regulatory Director Resume
1
Experience For Director Head of GMO Regulatory & Accounting Controls Resume
- Develop and deliver initial correspondence with the FDA and manage interpretation of FDA comments. Oversee and guide follow-on correspondence, such as resubmissions
- Ensures that processes are established to implement and communicate the effectiveness of the QMS to employees
- Demonstrates a willingness to take calculated risk and generate innovative options
- Build unified relationships throughout the University community by chairing and/or serving on various University committees or task forces
- Leading Quality and Regulatory functions within the medical device industry
- In-depth knowledge of regulations and standards affecting Medical Device & Diagnostics companies
- Analyze legislation, draft position papers and lobbying materials
- Act as liaison with state trade associations and coalitions representing the company's interests
2
Experience For Director, Government & Regulatory Affairs Resume
- Coordinate with Regional VP of Government Affairs on all matters relating to Company relations with governmental entities
- Provide strategic input to GPT and DRA team on key HA documents, obtaining appropriate line endorsement as appropriate
- Actively represent commercial regulatory for Core Data Sheet (CDS) and U.S. product label development
- Support development of the cross-functional regulatory strategy for each product or portfolio assignment by providing commercial regulatory affairs expertise, insights, perspective and recommendations
- Provide oversight and decision-making leadership to junior CORA staff as well as day-to-day guidance to other CORA team members supporting the same PRCs or other assignments
- As assigned, lead or otherwise participate in special projects and act as a standing or ad hoc member of other teams
- Keep internal partners and stakeholders abreast on primary PRC/CORA activities and status
- As appropriate, participate as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products
- Provides leadership for a globally diverse team under the strategy and vision of the business unit head
3
Experience For Director Quality Assurance & Regulatory Affairs Resume
- Develops client/Company relationships, directs large clinical trials, and provides input to bid defense
- Reviews and approves time records, expense reports, requests for leave, and overtime
- Oversees the Philadelphia based surveillance analyst team with a current focus on post trade surveillance of Nasdaq’s six options
- Contribute to the Operating Platforms strategy by creating 1-3 year plans for Regulatory Intelligence aligning Regulatory Intelligence with the other Operating Platform functions and contributes to developing the goals and objectives for the Regulatory Intelligence function, Operating Platforms and Regulatory Affairs department
- Responsible for tracking of legislative processes for upcoming regulations and enforcement, including data mining, selection, analysis and targeted dissemination of regulatory information to RA and cross-functional stakeholders by means of newsletters, email alerts and educational meetings
- Responsible for management of company internal processes around draft /final guidelines incl. impact assessments resulting in input into guideline consultancy processes in line with the Astellas strategy
4
Experience For Director, Global Regulatory Sciences Strategy Resume
- Responsible for management of RA related internal websites, databases, electronic information and distribution systems
- Responsible for company internal consultancy on regulatory information, availability, interpretation of regulatory documents and regulatory advice on request to senior and top management including special purpose reports
- Responsible for providing consultation during the drafting of product development plans
- Participate and coordinate participation in industry working groups including PhRMA, JPMA, EFPIA and BIO and participate and coordinate participation in Public-Private Partnerships or consortia such as IMI and Transcelerate to represent Astellas
- Has lead cross functional teams through key milestones meeting(s) with Health Authorities (preferably FDA), including management/delivery of the interaction
5
Experience For Director, Quality & Regulatory Compliance Resume
- Contribute to the development of best practices for Regulatory intelligence
- Represent Pharma Technical Regulatory in or lead internal and global cross-functional compliance projects and initiatives to drive the implementation and development of Roche/Genentech’s Pharma Quality System or to develop solutions for emerging new regulations impacting compliance aspects or regulatory operations
- Lead FDA meetings/activities with FDA’s CDER and/or local district offices on Drug Shortages, Counterfeits and other technical regulatory compliance issues on behalf of Genentech/Roche
- Substantial direct experience of working at the Regulatory Authority interface and leading delivery of regulatory projects through key milestones and investment decisions
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company, CMC, SMG, etc., or experience at a health authority
- Participates in performance improvement initiatives and demonstrates the use of quality improvements in daily operations
- Has assumed a leadership role in a recent, successful major Regulatory submission to FDA and/or EMA/CHMP, such as sNDA/sBLA, NDA/BLA
6
Experience For Director of Clinical & Regulatory Affairs Resume
- Consistently demonstrating an ability to think strategically and critically evaluate risks to regulatory activities, taking account of external trends in both regulatory and business environment
- True team player, within and outside of Regulatory Affairs
- Coaches Cox leadership on tactics for maintaining good relationships with public entities and appearances before legislators. Ensures that the company’s activities and priorities are perceived in a positive light and that the company’s interests are fully and accurately advocated
- Disseminates company goals and direction to Government Affairs team. Works with team on development of individual team members’ goals and objectives in support of company and individual professional goals
- Regulatory representative, including mentoring and directing internal and external regulatory resources and representing the company’s regulatory function at regulatory body meetings
- Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
- Identifies training needs and provides for the training of all personnel performing activities that affect quality
- Prepares reports, tracks responses and coordinates communication regarding quality and safety issues to external regulatory agencies
- Works on a team to recommend and facilitate sustainability efforts to improve quality and patient safety, based on identified risks and hospital data. Regularly reviews the sustainability educational program for relevance, participation and effectiveness, and adjusts as needed
7
Experience For Managing Director Head of Regulatory Consulting Resume
- Serves as liaison between SEMC leadership and the system level regulatory groups to aggregate data and make recommendations on matters that affect compliance with quality and patient safety standards
- Designs measures to evaluate the impact of interventions on publicly reported measures. Works with Corporate analytics team identifying trends and highlights opportunities to improve
- Directs and supervises assigned personnel including performance evaluations, scheduling, orientation and training. Make recommendations on employee hires, transfers, promotions, salary changes, discipline, termination and similar actions. Resolves grievances and other personnel problems within position responsibilities
- Evaluates the effectiveness of the training provided
- Communicates to the organization the importance of complying with customer, regulatory and statutory requirements
- Establishes, communicates and enforces the quality policy and quality objectives (and periodically reviews them to ensure their continuing suitability)
8
Experience For Program Director Commercial Regulatory Resume
- Develops and recommends the budgets for the areas managed. Manages activities to assure financial goals are met
- Coordinates the assignment of tasks and helps resolve technical and operational problems. Evaluated the impact of solutions to ensure goals are achieved
- Provides effective direction, guidance and leadership over the staff for effective teamwork and motivation and fosters the effective integration of efforts with system-wide initiatives
- Develops and maintains policies and procedures necessary to meet regulatory requirements
- Ensures that department complies with SEMC-established policies, quality assurance programs, safety and infection control policies and procedures
- Develops and maintains established departmental policies, procedures and objectives
9
Experience For Global Program Regulatory Director Resume
- All responsibilities are essential job functions
- Maintains ISO 13485 quality system registration through a third-party registrar
- Maintains relationships with key contributors and clinical trial sites
- Coordinates submissions for the purpose of gaining regulatory clearance for markets in which OPKO’s point-of-care products are sold – including FDA submissions for the US market and CE marking for the European Union
- Oversees regulatory compliance for the purpose of maintaining the products’ CE marking and FDA approval
- Assigns, directs and evaluates the work of Quality Assurance Department and clinical personnel; also oversees the development and maintenance of staff competence
- Ensures that customer needs and expectations are determined, converted into requirements and fulfilled with the aim of achieving customer satisfaction
- Ensures the QMS is effectively established, implemented and maintained in accordance with ISO 13485, 21 CFR 820 Quality System Regulation and all applicable regulatory requirements
- As management representative for quality, evaluates the performance of the QMS and reports quality and nonconformance data trends to top management as a basis for review and improvement
10
Experience For Senior Regulatory Program Director Resume
- Participates in risk management activities and approves product release in accordance with risk management procedures
- Directs and/or conducts periodic internal audits to determine whether the QMS conforms to planned arrangements and the requirements of applicable standards
- Ensures that product that does not conform to specified requirements is identified and controlled to prevent its unintended use or delivery
- Ensures that all employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives
- Identifies and provides the resources necessary to maintain the QMS
List of Typical Skills For a Regulatory Director Resume
1
Skills For Director Head of GMO Regulatory & Accounting Controls Resume
- Interface effectively with associated drug/device development teams
- Collaborate effectively with external development partners
- Gain commitment -- effectively uses interpersonal abilities to build relationships and gain acceptance of ideas
- Builds effective partnerships -- identified opportunities and takes actions to build effective relationships within team and with other areas
- Leadership -- effectively role models the culture & values and expertly guides the team to its common mission
- Proven track record in delivering results, self-starter and ability to manage complexity and deals well with ambiguity and new areas is required
- Experience working with all levels of the organization, particularly mid- and senior-level executives
2
Skills For Director, Government & Regulatory Affairs Resume
- Experience in strategy, planning and delivery of internal and external campaigns
- Experience with developing a Regulatory Intelligence Strategy
- Recent experience with initial NDA/BLA filing, with the FDA or MAA with EMA/CHMP
- Min. 5 yrs. experience in a government affairs role with a Canadian financial services firm or business association or within government
- Good management, interpersonal, communication
- Proven success in global Class 1 and 2 medical device regulatory submissions and clearance/approvals
- Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends is required
- Support development of therapeutic-area strategy for CORA, conducting and summarizing product-specific analysis as requested
- Gain increased understanding of company strategies, decision processes and implementation processes
3
Skills For Director Quality Assurance & Regulatory Affairs Resume
- Learn to leverage personal impact by addressing complexity, setting priorities, translating strategies into operational goals and objectives, exerting leadership to enhance organizational performance
- Provide strategic input to GPT and DRA team on key Health Authority (HA) documents, obtaining appropriate line endorsement as appropriate
- Provide strategic regulatory input into Business Development & Licensing (BD&L) Due Diligence evaluations as required
- Ensure that Regional/Country input is sought and incorporated into global regulatory strategy
- Obtain timely consultation with DRA line management and Novartis advisory boards on regulatory strategy
- Work directly with the AVP, VP and the broader Government Affairs team and other senior SLF representatives to anticipate and assess the impact of potential public policy direction, legislation and regulation on SLF Canada’s business operations and develop and implement strategic outreach plans
- Lead regulatory affairs files from a government relations perspective, working closely with Legal and Compliance
4
Skills For Director, Global Regulatory Sciences Strategy Resume
- Make recommendations on industry sponsorships and manage relationships with various industry/stakeholder groups, including meeting with industry associations and government representatives at various roundtable discussions and events
- Fully bilingual with excellent communication skills (both written and oral) in both French and English
- As necessary, assist the Government and Regulatory Affairs team on projects as they pertain to key SLF businesses
- Coordinate and organize internal stakeholders
- Learn complex issues quickly and to simplify them for public consumption
- Knowledge of Federal and provincial (Quebec) public policy issues related to wealth management, insurance, savings, and financial sector policy
- Knowledge of the workings of federal and provincial governments and the public policy process, with a focus on the Quebec government
- Provide strategic input to GPT and RA team on key Health Authority (HA)/ Notified Bodies regulatory documents including CE Technical files, obtaining appropriate line endorsement as appropriate
5
Skills For Director, Quality & Regulatory Compliance Resume
- Excellent interpersonal, leadership, presentation and collaborative skills to work effectively with leadership and teams across the organization
- Strong written and verbal skills, ability to adapt communication to different target audiences
- Five (5) years’ experience in position requiring high levels of cooperation, collaboration, and management of staff
- Experience required in related field (i.e. law, public policy, lobby, advocacy, etc.)
- Strong ability to execute and manage projects and details
- Excellent proficiency with MS Office (i.e. excel, PowerPoint, word, etc.)
- Excellent written and verbal communication – i.e. the ability to craft a clear and succinct message
- Experience interacting with state agencies and legislative officials
- Proven success in collaborating with EU Notified bodies to gain medical device clearance/ approvals
6
Skills For Director of Clinical & Regulatory Affairs Resume
- Quality, compliance and regulatory experience in the medical device industry
- Lead RA activities regarding Novartis safety risk communications for the assigned projects
- Provide strategic regulatory input into Business Development & Licensing (BD&L) due diligence evaluations
- Provide strategic input, review and approve study protocols and protocol amendments
- Technical and Business Expertise – Has a firm grasp of internal and external conditions affecting the organization. Applies emerging knowledge and trends in one’s area of expertise to improve results. Builds strong relationships with key customers. Contributes expertise to help colleagues within and beyond his or her area
- Work independently on several concurrent projects with differing requirements
- Willingness and ability to travel where and as often as needed
- Learn new processes quickly and with minimal background
- Identify and cultivate relationships with key stakeholders; gain the cooperation of peers and colleagues, persuade others; mobilise people to take action
7
Skills For Managing Director Head of Regulatory Consulting Resume
- Experience managing direct and indirect reports
- Managing an audit program and conducting audits in the medical device or drug industry
- Driver's License with clean driving record required
- Innovation in regulatory strategy
- Work in an office setting with standard office equipment, computers, and phones and be physically able to travel domestically and internationally (Travel is 30-50%)
- History of advocacy on communications industry related issues desirable
8
Skills For Program Director Commercial Regulatory Resume
- Leadership role in health authority negotiations in multiple regions
- Licensure as a registered nurse or a related health care discipline in the State of Maryland or eligible for licensure in Maryland
- Coach and mentor to others -- sought out to mentor others and identifies as well as develops regulatory talent, with commitment to learning and personal development
- Eight years of experience working closely with Clinical / Regulatory / Safety / Research laboratories with a demonstrable interest in IT systems
- The ability to work in a complex, business critical and high profile environment building credibility in ambiguous situations
- Promote new ideas and business solutions that result in extended services to existing clients
- Maintain and periodically update EMEA RRG Procedures and work with global colleagues to implement policy changes
- Able to develop relations, negotiate and influence regional authorities
- Direct and drive the success of multiple engagements
9
Skills For Global Program Regulatory Director Resume
- Basic Knowledge of US and EU regulatory laws
- Supports management with site start-up and financial management tasks of projects, as well as strategy development for process improvement. Facilitates and supports project reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis. Guarantees SSU delivery of assigned projects
- Leads teams of subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes. Develops and implements strategies and tools for tracking contract management team metrics/cycle times. Oversees all quality control efforts of individual departmental teams
- Lead/chair PRCs and effectively collaborate with cross-functional internal groups and external advertising agencies; acting as the decision-maker for PRCs in the assigned therapeutic or business area
- Monitor PRCs and provide management oversight for various scenarios that require such oversight, e.g., Food and Drug Administration (FDA) communications, audits, POC presentations, compliance violations, etc
- Represent Genentech in official FDA communications and sign-off on 2253s
- Act as a primary Roche liaison to the FDA on relevant CORA activities
- Stay abreast of developments in therapeutic and disease areas, including the competitive landscape and other relevant commercial and development trends and dynamics to ensure a fully current view of implications for Genentech products
- Obtain and apply in-depth knowledge of Roche and regulatory guidelines, policies, procedures and best practices
10
Skills For Senior Regulatory Program Director Resume
- Maintain current awareness of evolving FDA opinions; including advisory letters, enforcement letters and policy issues. Communicate significant changes or other relevant matters to internal partners and stakeholders
- Collaborate with commercial leadership to influence marketing strategies, implementation and promotion objectives
- Facilitate the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from the FDA and Roche policies
- Develop and implement effective strategies for FDA marketing, advertising and communications submissions
- Define, operate, and test/substantiate controls across the Bank’s 17 risk categories within GI&TRM
- Contribute to cross-functional initiatives representing the Regulatory Intelligence function and/or Regulatory Affairs department
- Provide regulatory input on commercial concepts and draft materials
List of Typical Responsibilities For a Regulatory Director Resume
1
Responsibilities For Director Head of GMO Regulatory & Accounting Controls Resume
- Develops good University citizenship by representing the University on outside professional associations
- Budgeting – Develops and monitors projections for insurance, self-insurance, and reserves
- Responsibilities also include recruiting, screening and hiring qualified staff as well as counseling and terminating staff if necessary
- Determines short-term objectives and develops and evaluates long-term strategic risk plans, which aim to fulfill the University’s mission and vision
- Proactively evaluate and improve procedures and protocol to better manage institutional risk
- Provides leadership to risk management team by meeting regularly, monitoring goals/objectives and evaluating performance to improve effectiveness and efficiency, by providing helpful and supportive feedback, and by sharing of knowledge and experience through mentoring
- Chairs or serves on University related committees
- Minimization of contractual liability loss exposures – Reviews contracts with outside organizations to advise management on the appropriate contract conditions to minimize contractual liability loss exposures
2
Responsibilities For Director, Government & Regulatory Affairs Resume
- Commercial insurance contracts – Negotiates all commercial insurance contracts (Liability, D&O, auto, Crime, environmental etc.) pertaining to policy premiums and coverage conditions. Manages settling of all recoverable losses against commercial insurance
- Property insurance – Manages all property insurance arrangements including administration of a self-insurance program for retained loss, together with periodic reviews of the values (property and business income) to be covered
- Works with University affiliated organizations to assure coordinated coverage and claims management process are implemented including but not limited to Sheraton, Drumlins, Syracuse Stage, SU Alumni Association and international programs and entities
- Oversee University tort and liability related (non-employment) claims and litigation
- Review and approves property, automobile, liability and workers compensation settlements. Work with defense counsel and insurance carriers in case preparation and settlement posture
- Conduct quarterly litigation/claim review meeting with liability and workers compensation. posture. Monitor case development and reports status to Executive Vice President for Business, Finance and Administrative Services
- Workers’ Compensation. Provides high level oversight on all employee claims for occupation-related injuries or illnesses. Evaluates return to work and light duty opportunities across campus. Works with campus safety professionals to prevention losses
- Provide services with respects to reimbursement for emergency related costs from the appropriate sources, such as the Federal Emergency Management Agency (FEMA) or insurance providers
- Develops and implements policies and best practices to help schools/colleges and departments comply with federal, state and local laws, regulations and policies within their current reporting structures. Coordinate these efforts and assess University-wide performance
3
Responsibilities For Director Quality Assurance & Regulatory Affairs Resume
- Formulates and communicates compliance strategies, goals and objectives to identify and mitigate risk and implement corrective action plans, as necessary, to resolve issues
- Serves as resource to schools/colleges/departments that have questions relating to federal, state and regional higher education laws, regulations and policies
- Conducts internal reviews and/or audits as needed
- Advances the University’s international/globalization and domestic objectives by incorporating risk management efforts in the areas of, travel safety and business operations
- Coordinates enterprise risk management efforts
- Collaborates closely with the Director of International and Domestic Travel Safety and Support, with international and domestic risk management functions
4
Responsibilities For Director, Global Regulatory Sciences Strategy Resume
- Main point of contact for the Mountain West Region External Affairs team in assigned geographic area and is responsible for creating, establishing and maintaining relationships on behalf of the company with elected officials, business leaders and community influencers in those specific locations
- Assists External Affairs team in maintaining overall budget
- Develops, presents and leads company initiatives in assigned geographic area
- Manages outside counsel, consultants, or lobbyists to implement strategies or initiatives. Provides leadership and supervision to Government and Regulatory staff including staffing, performance management, compensation administration, office management, etc
- Responsible for relations with Oregon state government, including advocacy before the legislature, executive branch and state agencies
- Travel to attend meetings, hearings, or other events to represent the company
5
Responsibilities For Director, Quality & Regulatory Compliance Resume
- Integrate and coordinate with Comcast's overall corporate government affairs efforts
- Coordinate participation by Oregon-based Comcast personnel in state government relations efforts
- Manage outside counsel, consultants, and lobbyists to implement strategies or initiatives
- Assist in reports and compliance activities that are required by the Company
- Ensure that Regional/CPO input is sought and incorporated into global regulatory strategy
6
Responsibilities For Director of Clinical & Regulatory Affairs Resume
- Partner with regions to align on regulatory strategy in order to fulfill business objectives
- Provide strategic input, review and approve clinical study protocols and protocol amendments Lead DRA activities regarding Novartis safety risk communications for the assigned projects. Provide strategic regulatory input into BD&L Due Diligence evaluations as required
- Develops and oversees execution of strategies by Government Affairs team for federal, state, local, and other public policy agency legislation
- Manages relationships with local franchise authorities, state and local elected officials and other public opinion leaders to maintain the company's positive image and ensures an optimal operating environment
- Develops and manages government affairs budgets and leads long-term strategic planning initiatives
7
Responsibilities For Managing Director Head of Regulatory Consulting Resume
- Develops, plans and implements grass-roots campaigns to advance company interests
- Employee Opinion Survey: Actively guides staff to select and work towards solutions for their identified concerns
- Meeting Preparedness: Effectively leads meetings or actively participates in agenda-related topics. Provides relevant reports and/or feedback that contributes to hospital policy, initiatives, and action plans
- Project Management: Systematically plans, organizes and manages resources to bring about successful completion of specific project goals. Monitors progress using processes and or project management tools
- Risk Taking: Displays a willingness to make decisions and enact action steps in an environment of Provides oversight, direction, and education for quality service functions
8
Responsibilities For Program Director Commercial Regulatory Resume
- Provides oversight, direction, and education regarding regulatory compliance
- Respect for individuals, Customer Service, Teamwork and Collaboration
- Facilitates processes, resourcing, and communications within a department, across departments, or within the country assigned. Acts as liaison and facilitator between customer leaders and senior management for related tasks and/or issues. Plans and negotiates resources with line management of functional areas. Serves as a departmental point of escalation for internal and external customers
- Manages key systems and processes in order to maintain and continually improve compliance with ISO 13485, FDA Quality System Regulation, the European Union IVDD and the Canadian Medical Device Regulation (CMDR) (when these standards and regulations are applicable to company products), as well as the regulatory requirements of other markets in which the company sells its products
- Suspends manufacturing, inspection and/or testing activities and/or authorizes product recalls or other regulatory notifications if any of the following occurs: 1) Product requirements are not being met; 2) Products could adversely affect OPKO’s ability to meet customer requirements; or 3) Products could potentially cause harm to end users or to patients using OPKO products
- Organizes and directs all franchise renewal efforts in the assigned area, including developing and implementing franchise renewal strategies consistent with corporate guidelines; secures timely franchise renewals on acceptable terms; manages the maintenance of local franchise administration and database information; and ensures the timely delivery of franchise renewal notifications
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• Prior experience with social media managem...
Regulatory Office Resume Sample
Work Experience
• Drive & manage improvement programs for regulatory reporting control, including understanding the existing issues, identifying the root cause and implementing remediation
• Follow the escalation protocols for regulatory breach incidents by organizing debriefing meeting, Phoenix/FORCE uploads
&n...
Professional Skills
• Provide informed skill set to deliver chan...
• Post graduate education in business or a r...
• Effectively communicate and/or escalate is...
Regulatory Risk Resume Sample
Work Experience
• Detailed business analysis/requirements definition across our data and core capabilities streams of delivery
• Direct, daily interaction with business & operations reporting SME’s to manage the information flow and delivery of key project milestones
• Work with Controls a...
Professional Skills
• Strong project management skills, proven o...
• Strong analytical skills alongside the abi...
• Proven managerial skills including setting...