Director Regulatory Resume Sample
Cicero Heaney
473 Aubrey Manors,
Detroit,
MI
+1 (555) 947 6175
Work Experience
Director, Regulatory Consulting
08/2017
-
PRESENT
Houston, TX
- FDA REMS Submission
- FDA REMS Knowledge, Attitude and Behavior (KAB) Survey Activities
- FDA REMS Assessments
- FDA REMS Stakeholder Audits
- Provide Vertex senior management with position statements/talking points to: 1) influence evolving external environment and 2) establish the regulatory advocacy voice of Vertex
- Identify and respond to US regulatory/legislative policy issues that impact research, development and lifecycle management
- Provide thought leadership in US regulatory policy and maintain/develop mutually beneficial relationships with key leadership at Health Authorities and other external stakeholders
Director‚ Regulatory Consulting
05/2011
-
03/2017
Chicago, IL
- Drive Vertex agenda through participation on US external committees and coalitions (i.e. major trade associations, public private partnerships, academia etc)
- Support US regulatory affairs and product development with focused regulatory strategy derived from deep knowledge/understanding of regulatory external/competitive environment
- Develop cross-functional communication and implementation plans to convey complex regulatory policy issues with impact to the business. Ensure external analysis is internalized to facilitate product strategy; track progress
- This leadership role requires significant interaction and influencing with senior management across the company
- Work effectively and effortlessly in a highly collaborative and team oriented environment are essential components in this role
- Continue to develop and stream line processes and become a champion of innovation and technology, ensuring the highest standards are maintained
- Ensure compliance metrics and root cause analysis are at the heart of a culture of continuous improvement
- Take the lead in Audits, inspections and CAPA activities and ensure adequate quality measures are in place
Director, Regulatory Strategist
06/2005
-
04/2011
Detroit, MI
- Provide support for RFPs and bid defence
- Develop key performance indicators eg quality, productivity and resource planning
- Develop current/ new service offerings to aid business growth
- Proactive management of staff and the resolution of business issues
- Excellent interpersonal, communication, analytical and managerial skills
- Demonstrated experience with global development, registration and post-approval submissions
- Work successfully with cross-functional teams and influence appropriate plans and actions
- Other Job Components
Education
Temple University
1999 - 2004
Bachelor's Degree in Life Sciences Required
Professional Skills
- Pharmaceutical industry experience, including 5-7 years in regulatory affairs. 5 years experience with OPDP and the review of advertising and promotional materials is required
- Demonstrated verbal communication skills, including the ability to communicate effectively with senior executives
- Leadership skills and demonstrated ability to influence promotional review teams and other cross-functional teams required
- Innovative, flexible and collaborative with demonstrated leadership skills
- Strong written communication skills, including the ability to make clear and persuasive submissions to government and senior officials
- Industry regulatory experience, 5 or more of which In the regulatory labeling, and some management experience
- Attention to detail and strong word processing skill
How to write Director Regulatory Resume
Director Regulatory role is responsible for regulatory, government, negotiation, english, analytical, leadership, securities, finance, training, database.
To write great resume for director regulatory job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Director Regulatory Resume
The section contact information is important in your director regulatory 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 Director Regulatory Resume
The section work experience is an essential part of your director regulatory 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 director regulatory responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular director regulatory position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Director Regulatory resume experience can include:
- Leads Regulatory Solutions’ communication plan and acts as key contact for marketing, client and employee regulatory communications: Develops and reviews employee and client regulatory communications
- Prior line management experience, preferably managing other managers
- Experience operating in a complex, matrixed management environment
- Significant experience either within the UK FCA, an Investment Bank or a Big 4 firm/ mid-tier accounting firm
- Strong knowledge of banking rules and regulations
- At least ten (10) years experience in the energy industry with 3-5 years of that time in a regulatory role
Education on a Director Regulatory Resume
Make sure to make education a priority on your director regulatory resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your director regulatory 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 Director Regulatory Resume
When listing skills on your director regulatory 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 director regulatory skills:
- Enables and demonstrates the courage to speak up on issues and risks as well as on the good news
- Exceptional oral and written communication skills and presentational expertise
- Take ownership and bring a specific strong expertise to the Conducting Officers team, in at least one of the following areas
- Experience leading interdisciplinary initiatives in process improvement and directly with improving reliability of healthcare delivery at the point of care
- In-depth understanding and experience of conducting market research and analysis
- Experience leading a multi-hospital system Regulatory and Accreditation program
List of Typical Experience For a Director Regulatory Resume
1
Experience For Director, Regulatory Consulting Resume
- Specific subject matter expertise regarding technology application control disciplines and a strong business understanding of ICG products, especially those associated with the Securities Services business
- Establish and maintain relationships with elected and non-elected government officials, financial sector policy makers, key industry opinion leaders and other stakeholders to articulate and advance RBC’s views and enhance RBC’s reputation as a credible voice on public policy issues
- Handle multiple projects and prioritize work independently
- Leading on a wide range of prudential regulatory engagements including capital, liquidity, treasury management, governance and wider controls
- Draft external communications (including position papers, issue briefs, and comment letters) and represent TIAA’s views with external stakeholders
- Client facing, solutions focused, individual
2
Experience For Director, Regulatory Strategist Resume
- Monitor revenue and costs dynamically in conjunction with the Managing Director
- Ensure, collegially and as a member of the Conducting Officers team, adherence to legal and regulatory requirements
- Assist in the assessment and rating of business regulatory risk in respect of conflict management related matters
- Support Global Business lines in discharging their responsibilities to comply with applicable laws, rules and regulations
- Monitor and track performance/success of commercial activities using key metrics and prepare reports to senior management
- Represent RBC’s interests in industry consultations and trade association processes and at conferences and seminars on financial sector issues
- Strong analytical skills in interpreting the business implications of legislation and regulations, with a thorough understanding of regulatory, legislative, and political processes and of how to develop and implement strategies to advance public policy objectives
3
Experience For Director Regulatory Policy & Intelligence Resume
- Work with minimal direction, particularly in areas of specialization
- Innovativeness and ability to multi-task, in order to simultaneously manage diverse subjects and tasks
- Understand and interpret across a broad range of complex issues
- In the finance services industry or similar
- In-depth knowledge of the labeling process, industry practice, packaging manufacturing process, and the drug development process. Familiar with policies and operating procedures in medical safety regulatory and/or corporate and worldwide Regulatory Agencies
- Lead Cross Functional Labeling Team (CFLT) to address labeling issues, develop plans of action, and oversee completion of labeling project
4
Experience For Director, Regulatory / Quality Resume
- Familiarity with FDA, EMEA, and international labeling regulations, ICH guidelines, and CIOMS core labeling guidelines
- Assimilate clinical and scientific information, and present it in a concise manner
- Work independently and use judgment to make decisions and escalate problems appropriately. Proactively share information with peers and generate discussion to resolve complex issues
- Proven experience in the understanding and interpretation of regulation within the Investment Management/ Custody / investment banking industry and the implementation of solutions to address regulatory requirements
- An appreciation of the impact of regulatory changes, risk based approached and current matters facing the industry
- Implementation of practical and risk-based solutions to address regulatory requirements
- Clear, logical thought process, ability to arrive at and make decisions and articulate these clearly. Ability to argue rationale for decisions
- Has significant exposure to regulatory environment in Asia Pacific preferably in a regional capacity
- In-depth knowledge of role of regulatory in drug development including clinical development, market authorization, orphan drug status and post approval commitments in Japan
5
Experience For Director, Regulatory Compliance Strategy Resume
- Excellent verbal and written English communication skills, with the ability to collaborate with regulatory and other functional teams across cultural and geographic boundaries
- The ability to project a professional demeanor and be a respected and credible partner for clients, external thought-leaders and health agencies
- Continuously interact with regulators, stakeholders and internal company experts to identify and proactively pursue results that reflect Xcel’s regulatory and legislative policies and strategies regarding matters such as development and cost recovery of utility infrastructure and other utility business
- BA/BS in areas of responsibility
- Knowledge of utility industry and issues and the legislative process is required
- Work well with a wide variety of stakeholders
- Swift and efficient communication to various key stakeholders that include clients, Board of Directors of the Management Committee, Regulators and service providers
- Be responsible for managing the team and oversee the daily activities
6
Experience For Associate Director, Regulatory CMC, Biologics Resume
- Presents convincingly in client interactions
- Document, implement and continuously improve Leica Biosystems’ Quality Systems and regulatory processes and activities
- Primary point of Regulatory Compliance contact for Global Control Room related matters
- Advise Global Business lines on the impact on the business of applicable laws, rules and regulations
- Escalate all material and significant breaches or potential breaches of regulations as soon as practicable to Global Head of Control Room or the relevant Regulatory Compliance Officer
- To escalate regulatory breaches to business and Regulatory Compliance Senior Management in order that appropriate action can be undertaken to rectify
- Foster a close working relationship with the local advisory teams and business, including keeping abreast of key business developments and any changes to procedures and practices
7
Experience For Director, Regulatory Projects Resume
- Timely production of high quality Management Information
- Ensures compliance with power purchase agreements, land leases, financings and regulatory requirements
- Work with the Global Head of Regulatory Consulting and CRC Managing Directors in Europe primarily to develop and implement commercial strategies, plans and marketing/brand initiatives that are aligned to the practice’s goals and objectives aimed to accelerate growth
- Work with CRC Managing Directors to develop existing commercial propositions and new opportunities identified through research, as well as acquire new customers and manage client relationships (new and existing) through design of sales/marketing campaigns, preparation of go-to-market materials and support on strategic opportunities/pitches
- Support Managing Directors in the business planning process to ensure that commercial strategies are aligned and achieved/maximised through opportunities and propositions
8
Experience For Director Regulatory Compliance Control Room-personal Account Dealings Resume
- Undertake mapping exercises of services across Duff & Phelps service lines and industries to establish synergies with CRC and go to market strategies for cross- and up-selling opportunities
- Understand the requirements of existing customers to ensure our service and propositions are aligned and meet those needs
- Conduct market/internal research and analysis to
- Proactively create business cases and plans for commercial opportunities, such as expansion, business development, creation or development of existing propositions and revenue streams
- Feedback and recommendations to further improve business
- Ensure that our CRC brand, positioning and propositions are clearly understood by the CRC and wider stakeholders to articulate to clients, within the broader Duff & Phelps brand positioning
- Collaborate with and coordinate diverse teams including CRC divisions, cross-service lines and support functions, in particular Marketing and Human Capital. Work closely with Marketing to prioritise and deliver on agreed activities to achieve commercial and brand objectives
- Assist the Global Head of Regulatory Consulting with succession planning and recruitment, onboarding, training and development, reviewing and the retention/engagement of CRC staff. This includes developing and maintaining a compelling employee value proposition, as well as supporting cultural or change initiatives as they arise
- Ensure CRC teams across the globe feel connected, aware of our strategy, mission, propositions and ongoing campaigns through strategic internal communications and engagement activities
9
Experience For Director Regulatory Relations Resume
- Plan, edit and write content for a variety of internal and external communications content to achieve objectives, with a strong understanding of the strengths and weaknesses of different communications channels for different audiences and situations
- Strong commercial acumen partnered with a strategic mind-set with proven experience in commercial, marketing and/or sales, stakeholder management and project management
- Strong communication and interpersonal skills to build strong relationships with clients and partners, as well as to present complex information clearly and simply
- Strong knowledge, understanding and experience in developing and delivering brand, marketing, communications and engagement strategies, specifically its application to medium to large-scale global organisations
- A self-starter with a proactive, can-do attitude and the ability to work autonomously but also collaboratively within a team environment, whilst prioritising and balancing conflicting demands
10
Experience For Director Regulatory Consulting Manager Resume
- Collaborative, consultative, inclusive working style, with the gravitas and ability to work with and positively influence c-suite and audiences throughout the organisation
- Continuous monitoring of regulatory change and ensuring the team’s knowledge is kept up to date
- Analyse new regulation and legislation, identifying impact on target market and potential client offerings
- Work on wider projects including Financial Crime, Due Diligence and Markets regulation
- Serves as single POC for Vaccines and Biological Products
- For Vaccines and Biological products creates and maintains a database of country requirements for health authority registration/approval
- Supports RAI Liaisons to provide regionally focused strategic input to product development across region and across portfolio
- Triages questions and to responds to those asking about location of certain information in the Dossier and forward those to HQ which require subject matter expertise
- Ensures alignment of strategy and priorities for portfolio of products with stakeholders, e.g. GHH, MMD
List of Typical Skills For a Director Regulatory Resume
1
Skills For Director, Regulatory Consulting Resume
- Translates broad strategies into specific objectives and action plans that can be effectively executed by external partners
- Strong understanding of current and emerging technologies designed to enhance DSI’s business processes and practices
- Solid knowledge of performance reporting and business planning processes
- At least 10 – 15 years' of regulatory affairs experience gained working in a CRO and/or pharmaceutical industry
- Demonstrates ownership of results within (and beyond) area of responsibility
2
Skills For Director, Regulatory Strategist Resume
- Demonstrates resilience and perseverance
- Orphan Drug experience is also essential
- BS/BA in areas such as Chemistry, Biochemistry, Microbiology, engineering, or equivalent experience
- Strong understanding of US and European Regulatory Affairs and procedures would be beneficial
- Experience in using regulatory data bases (e.g. Cortellis, Pharmapendium) is required
- Operate under pressure and within tight time-frames, within a flexible environment
- Phase out, oversee, project-manage and coordinate delivery for the various assignments, under strong standards of quality and responsiveness
- Formalize and strengthen the company’s procedures to constantly improve operational effectiveness
3
Skills For Director Regulatory Policy & Intelligence Resume
- Foster good relations with all relevant regulators
- Taking a lead role in continuing to develop the prudential service offering
- Managing the risks surrounding conflict management
- Liaising with industry bodies and regulators
- Sets challenging, but regulatory achievable objectives, comfortable taking risk in the regulatory setting
- Recommends changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance
- Knowledge of FDA advertising and promotion regulations and guidances is necessary
- Excellent communication, listening, and negotiation skills, the ability to strategically influence business partners and FDA, and a mature appreciation of how the commercial objectives of the company can be delivered, while at the same time meeting FDA compliance standards, are necessary
- Identification of required supporting actions and intermediary outcomes
4
Skills For Director, Regulatory / Quality Resume
- Description of business, regulatory deliverables, operational impacts, user communication, training and implementation
- Develops contingency plans and meets challenges necessary to execute business and action plans. Ensures these plans are feasible using external resources
- Creates a unified and seamless team using both internal and external resources to execute regulatory strategy
- Creates an environment that encourages continuous improvement, innovation and appropriate risk taking
- Contributes to the development of long-term strategies and plans for the business unit/department
- Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems
- Partner with Regulatory Ops Director in development of training strategy with Comcast University
- Participate in site senior business leadership meetings; develop and drive strategies and programs, which improve the competitive position and profitability of the organization
5
Skills For Director, Regulatory Compliance Strategy Resume
- Contributes to the total effectiveness of the department, communicating openly, solving problems proactively, offering creative ideas and working as a positive, engaged team member
- The identification of desired business outcomes and underlying assumptions
- Define project scope and deliverables through
- Determination of business and technology costs, risks and benefits
- Identification of prerequisites and dependencies
- Determination of required resources, organizational structure and financial feasibility
- Business case and business requirements developement
- Preparation of appropriate Governance and risk management plans
- Generates alternative regulatory strategies and plans, and assesses benefits and risks
6
Skills For Associate Director, Regulatory CMC, Biologics Resume
- Seeks multiple perspectives and listens openly to others’ points of views
- Sets clear and high expectations and holds self and others accountable for decisions and results achieved
- Be aware of the Operational Risk, primarily Business Regulatory Risk associated with the business
- Coordinates and prepares document packages for regulatory submissions
- Compiles all materials required in submissions, license renewal and annual registrations
- Ensures accuracy and quality of regulatory submissions; generates and/or review regulatory documents to ensure appropriateness with regulatory requirements, agreements, and regulations
7
Skills For Director, Regulatory Projects Resume
- Reviews Federal Register and rest of world regulatory notices/websites and keeps abreast of regulatory procedures and changes
- Skilled communicator and facilitator with the demonstrated ability to represent Vertex as the Company’s lead liaison in opening doors for communications; a bridge-builder
- Experience in any of the following is highly desirable
- Work closely with the related Project Management Office as required, and ensure resourcing, budgets and deliverables are being met
- Industry experience in the capital markets, having covered multiple product areas and jurisdictions, either in the business or in a law firm environment. An LL.B./J.D. is highly desirable
- Work closely with the control groups including Legal and Compliance to understand and interpret the rules
- Assist in the preparation of presentation materials, progress report to stakeholders including senior management
- Act as RIG project manager and/or support a RIG project manager for selected regulatory projects
8
Skills For Director Regulatory Compliance Control Room-personal Account Dealings Resume
- Work closely with the desks in GBM and downstream support groups to implement infrastructure and processes to ensure regulatory compliance
- A PharmD or PhD in a life science is required
- Extensive knowledge of MDD, MedDev’s, FDA QSR’s, ISO 13485, and other for the market EMEA applicable regulations. Experience with Research and Development, Sales and Service, Manufacturing, Marketing, IT, Document and Data Management, Purchasing/Procurement, Logistics and Service/Installation
- Certified in Executive Nursing Practice (CENP) within 180 days of hire date
- Provide timely and accurate reporting of regulatory activity throughout SVB’s global footprint
- Provides quality control services by monitoring work results of direct reports
- Develops and implements associate training
- Certified Joint Commission Professional (CJCP) within 30 days of hire date
9
Skills For Director Regulatory Relations Resume
- PMP designation or Agile Scrum Certification is an asset
- Lean Six Sigma Black Belt an asse
- Develops operational budget as well as manages the departmental budget. Maintains and coordinates staff activities so as to achieve departmental and corporate company goals in improving service to customers and assuring regulatory compliance
- Responsible for analysis and development of strategies by achieving performance thresholds within budgetary guidelines
- Ensures that programs supports overall QI program and meets regulatory compliance/accreditation and Company standards.
- Performs audits to monitor efficiency and compliance with policies
- This job is Pfizer Exempt US Grade: 16
- Additional Location Information: La Jolla, CA; New York, NY; Collegeville, PA; Groton, CT; San Francisco, CA; Cambridge (MA)- Remote based; Milan, Italy; Walton Oaks; UK
10
Skills For Director Regulatory Consulting Manager Resume
- Ongoing communication of project status, completion of the Project Status Reports and escalation of issues to the stakeholders, Sponsor(s), and Senior Executive (to the SVP and up) in IOSS as well as business lines and operational groups, as required
- The ability to develop relationships across various stakeholders, including local and regional compliance advisory staff and the business
- Coordinates I&TS’ response to regulators’ requests for comments and participation in industry associations
- Keen attention to detail, as well as the ability to view the bigger picture
- The ability to proactively analyse problems and propose viable solutions
List of Typical Responsibilities For a Director Regulatory Resume
1
Responsibilities For Director, Regulatory Consulting Resume
- Individuals with other credentials and who possess an excellent working knowledge of Regulatory Affairs or Clinical Research gained within industry would be considered
- Proven ability to manage complex regulatory issues
- Proven ability to consistently deliver within time, cost and quality standards
- Primary liaison with the regulators by facilitating all examinations, recurring regulatory requests, and ad-hoc inquiries
- Accountable for leading the preparation of Global Regulatory Strategies and implementation plans (core labels, risk registers) for assigned projects
- Partner with project teams and other customers (e.g., Oncology Research Unit/Pfizer Oncology, Regional Commercial Teams) to ensure regulatory contributions (Global Regulatory Strategies, labels, INDs, CTAs, BLAs/NDAs, MAAs, sNDAs, etc.) meet business needs and are provided within agreed time, cost and quality standards
- Develop and maintain constructive working relationship with Health Authority contacts
2
Responsibilities For Director, Regulatory Strategist Resume
- Ensure an aligned regulatory position is reached and communicated for all key issues for assigned projects, and that these regulatory positions supporting the business are championed and communicated
- Work closely with other Regulatory Strategists within and across sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards
- Creates reporting for the senior management, bank committees, and the Board of Directors
- Attends meeting with the regulators and informs bank management of areas of potential risks
- Ensure business compliance, and implementation of and adherence to regulatory standards
3
Responsibilities For Director Regulatory Policy & Intelligence Resume
- Proven examples of delivery with demonstrable contribution in global Regulatory activities, including knowledge of IND/CTA, BLA/NDA/MAA and other submission processes
- Provide Regulatory Researcher support across BioMarin programs to support US and EU marketing license applications
- Work with trade associations to influence and draft new regulations and guidances to align with RB vision and direction
- Coaches and supports others in project management, systems, methods and practices, including contingency planning. Inspires project team members to take ownership and deliver project results. Challenges the team to increase effectiveness of overall project delivery
- Proficient (skilled as needed) in Microsoft Office programs, RB systems, key external agency and trade association websites. Leads and directs the development, implementation, and utilization of RB systems and SOP/work practices
- Relevant work experience required
4
Responsibilities For Director, Regulatory / Quality Resume
- Builds strong relationships with Comenity’s regulators
- Work with uncertainties and effect innovative solutions to complex regulatory requirements
- Results oriented, entrepreneurial and self-motivated
- Manages and coordinates responses to regulatory recommendations
- Partners with the business on all examinations and documentation requests
- Maintains a central repository of all regulatory communications and documentation provided to the regulatory agencies
- Assists on other projects, as needed
5
Responsibilities For Director, Regulatory Compliance Strategy Resume
- Excellent communication, interpersonal and negotiation skills in order to gain trust, achieve business objectives, and work directly with a broad group of managers throughout the company and regulatory bodies
- Tenacity and flexibility
- Creating a clear brand strategy and story for CRC (within the broader Duff & Phelps brand) to ensure it is fit for purpose and supports our growth ambitions, and bring it to life through the team ‘living’ the brand in everything we do – both internally and externally – that is underpinned by a culture, values and behaviours which creates the conditions for success
- Establish network of effective relationships with agency representatives on Trade Association teams related to specific guidance documents/areas of Agency regulation. Increased interactions with Regulatory Agency representatives - both directly related to product issues and in relation to emerging/evolving industry issues. Shares knowledge and experience with peers and subordinates
- Leadership position with government regulatory agencies, and key trade associations committees. Leads in the management of stakeholder interests and continually enhances relationships while building new stakeholder and company linkages. Responsible for communicating and co-developing initiatives with Global and local teams. Leads others in anticipating issues and seeing opportunities
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