Regulatory Lead Resume Sample
Sheridan Zemlak
966 Kuhlman Mission,
Philadelphia,
PA
+1 (555) 859 9026
Work Experience
Cib-cfs Complex Change Prod Dev Lead Regulatory
04/2018
-
PRESENT
Boston, MA
- 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
- Manages and facilitates development and review of the CCDS and US and EU labeling via the Shire Labeling Teams
- The US Lead is responsible for submissions to the FDA to support INDs and/or marketing authorizations
- Work with the business to create, document, and move CAP’s to resolution
- Improve internal processes for management of Regulatory & Audit engagements, ensuring controlled, consistent responses and ability to meet regulatory requirements
GTI Asia Audit & Regulatory Lead
10/2011
-
02/2018
New York, NY
- Work with Firmwide Cybersecurity colleagues and other internal teams, including but not limited to Legal, Compliance, Oversight & Control and management teams
- Managing regulatory portals (Case Assignment, Duplicates, Cases with no due dates, FCC Portal)
- Ensuring response adherence ot the regulatory agencies FCC, PUC, AG
- Running daily reports on cases, identifying proglems with case response, managing extension requests and preparing weekly reports, daily review of 'hot topic' cases to ensure proper legal review and attorney assignment
- Providing daily legal assistance, obtaining information or clarity as needed from regions for legal review, serving as mediator
- Responsible for the optimization of processes to support GRA’s strategies globally and ensure that the company’s regulatory programs are optimally designed and executed
- Provide objective assessment on the design and operating effectiveness of controls and governance. Identify risks and issues as appropriate
- Ensure timely execution of control sampling on completeness, accuracy and timeliness in transaction reporting in one or multiple asset classes. Identify non-compliance issues and improvement areas
- Monitoring SLA's between Quality Assurance, Middle Office and Regulatory Transaction Reporting teams
International Regulatory CMC Liaison Lead
08/2007
-
09/2011
San Francisco, CA
- Strengthen Citi's regulatory risk profile by: deepening the firm’s intelligence regarding areas of increased regulatory focus; strengthening practices to identify and resolve – across the region - control weaknesses identified in the course of regulatory exams
- Enrich the firm’s ability to track, report on and manage regulatory exam activity and results
- Represent GIRM in the CTO RRC management group and manage GIRM’s relationship with the COO Divisional Control & Regulatory Office
- Liaise with CTO RRC, - Divisional Control & Regulatory Officer (DCRO), and others on the Risk and Control Assessment of GIRM’s “owned” activities including identification of controls to address material risks and the assessment of design and operating effectiveness of controls
- Contribute directly to progress status meetings at the operational and project level
- Build and augment the local implementation of Citi’s Global Conduct Risk Program
- Manage the Compliance team’s core policy requirements as a department
- Supervise the Regulatory and Policy Advisory team’s partnership with regional colleagues concerning core policy escalations
- Provide input and expertise to the Global Medical Devices Scheme Manager & Technical Specialist Team, QMS Team and Commercial Team related to competence and certification
Education
University of Southern Nevada
2001 - 2006
Bachelor's Degree in Pharmacy
Professional Skills
- Excellent interpersonal skills – Confident, strong communication skills with good work attitude, proactive and willingness to go extra mile
- Strong, effective communication and organization skills
- Influencing skills, ability to manage conflict
- Prior experience of coordinating and managing large technology programs
- Be able to network internally and externally as well as have the skills to motivate others without the line management responsibility
- Proven track record working in the capacity as a Regulatory Labeling Lead/Manager or equivalent
- Experience with applying the principles outlined in regulatory examination handbooks
How to write Regulatory Lead Resume
Regulatory Lead role is responsible for interpersonal, training, procurement, planning, reporting, manufacturing, design, travel, government, risk.
To write great resume for regulatory lead job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Lead Resume
The section contact information is important in your regulatory lead 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 Lead Resume
The section work experience is an essential part of your regulatory lead 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 lead 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 lead position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Lead resume experience can include:
- Have the ability to deal effectively with organizational complexity and ambiguity
- Communicate effectively with managers and people at regulatory bodies
- Experience of developing and implementing local monitoring systems to ensure compliance with national standards (including CQC compliance)
- Experience with regulatory authorities and licensing
- Experience working with regulators is required
- Demonstrable experience of managing change within a clinical environment
Education on a Regulatory Lead Resume
Make sure to make education a priority on your regulatory lead resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory lead 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 Lead Resume
When listing skills on your regulatory lead 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 lead skills:
- Strong interpersonal skills, a high level of professionalism and the ability to establish effective working relationships with key business partners
- Effective active listening and critical thinking skills
- Experience working in a highly-regulated environment with a solid understanding of the Care Quality Commission (CQC) requirements
- Moderate situation handling and decision making skills
- A self-starter who motivates, has tact, diplomacy, leadership skills and a flexible and positive approach
- Effectively present information to senior management and to cross-functional teams
List of Typical Experience For a Regulatory Lead Resume
1
Experience For Cib-cfs Complex Change Prod Dev Lead Regulatory Resume
- Supplier performance measurement processes collecting and assessing KPI’s and consolidating them in supplier performance dashboards
- Updation of standard operating procedure pertaining to regulatory
- Provide the required support & documentation to the Company lawyer regarding the sealed samples when required
- Deliver audits of medical devices to maintain awareness of BSI’s systems
- Deliver certification decisions for medical devices CE certifications
- Drive the output and quality of Medical Device Technical Documentation Reviews, Audits and Certificate Recommendations through a continuous internal exchange of experience
- Support Compliance Manager in responding queries from local regulatory authorities within stipulated time
2
Experience For GTI Asia Audit & Regulatory Lead Resume
- Provide technical information to regulatory affairs department as and when required
- To Provide Support on technical information to Legal and Corporate Affairs Department in case of any query from Ministry of Health (e.g. Mis-branded, Counterfeit, Spurious, Substandard etc.)
- Management of the Regulatory Sealed samples
- Manage regulatory visits at site
- Management of regulatory quality intelligence
3
Experience For IT Regulatory Program Lead Resume
- Interaction with regulatory authorities, Courts, legal locally and outside the city
- Management of product registration document manufactured at site
- To ensure regulatory compliance for exhibit batches at site, as required
- To ensure all regulatory submissions, correspondence and approvals are accurately communicated, recorded
- Accountable for defining the International regulatory strategy for assigned products within the assigned therapeutic area (maintaining and extending Shire product registrations in International markets)
- Under direction of Head International Regulatory Strategy Group, designs international regulatory strategy for products that they are accountable for in close collaboration with the GRL to obtain, maintain and extend Shire products registration in the international markets
- Ensure international strategy is appropriately represented within the GRT and at other appropriate forums (PST, Global Development Team etc) through the GRL
- Leads cross-functional submission teams to ensure creation and submission of qualitative regulatory documents (MA, Briefing documents, ODD, responses to questions and other relevant regulatory filings) pertaining to the international region within defined timelines as per company objectives
4
Experience For International Regulatory CMC Liaison Lead Resume
- Ensure timely updates to product core dossiers for the assigned products and assigned therapeutic area
- Responsible for timely communication of issues and mitigation strategy for the assigned TA to line management and TA Heads and be the point of contact for the assigned TA
- Oversee direct reports within the assigned therapeutic area
- Actively trains/mentors direct reports and provide support to plans for development
- Ensure direct reports have objectives set within the agreed time frame
- Review/Clarify Audit RFI’s & issues raised
- Reviewing the financial performance of the UK entities’ CIB Technology function in line with financial plans agreed by the Global CIO, the Global CIB CIO, the legal entity boards and London Branch Oversight Committee
5
Experience For Global Regulatory Lead-development Products Resume
- Ensures that there is an appropriate governance structure for the UK entities’ CIB Technology function
- Communication of the firm’s culture and conduct standards in the UK entities’ Technology function
- Be responsible for establishing strong working relationships with Application Development, Information Security, Continuity of Business, as well as other Business/Operations/Infrastructure Risk Management teams l
- Facilitate compliance with Citigroup Policies, Standards and Regulations and identify gaps and remediation plans
- Manage preparation, writing, review of nonclinical components of regulatory submissions and all technical documents for which the department is responsible. Ensure timely delivery of high quality, submission-ready submission components that are consistent with relevant regulatory guidelines for global submissions (eg, US FDA, EMEA, PMDA, ICH)
- Formulates and implements regulatory strategy for crossfunctional labeling teams for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products
- Formulates regulatory labeling strategies for implementation of new and revised prescribing information and packaging
- Independently facilitates the development and review of CCDSs and US and EU labeling via labeling teams and executive committees
6
Experience For Global Regulatory Lead-neurosciences Resume
- Prepares submission-ready labeling components for US and EU Health Authority submissions
- Ensures that there is Labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans
- Expertise in EU and US labeling requirements/ guidance and familiarity with US legacy and PLR-formatted labeling. Ability to communicate and resolve issues during labeling reviews and discussions
- Understanding of Electronic Document Management Systems to a sufficient level to support version control and archival of labeling documentation
- Manage product specific inquiries from internal and external business partners and regulatory agencies; research, analyze, capture and report on trends related to inquiries
- Serve as primary liaison between regulatory entities and CareSource
7
Experience For Regulatory Labeling Strategy Lead Resume
- Provide accurate, timely and concise replies to requested data, questions, inquiries or reports from regulators
- Work collaboratively with the Compliance management team to develop training tools, onboarding program elements, and to provide hands-on training to Compliance team members
- Working in collaboration with Clinical Governance, Risk and similar compliance teams as part of a one-team approach to delivering regulatory compliance
- Facilitating stakeholder meetings
- Handle front-end information gathering for potential self-disclosures and ensure forms are completed timely
- People Management to include matrix reporting and virtual teams
- Develop and maintain relationships with key internal and external stakeholders to ensure successful collaboration
- Identify and recommend performance improvement opportunities
8
Experience For Global Seed Health Regulatory Lead Resume
- Report potential risks, non-compliance or alleged violations
- Coordinates efforts associated with the preparation of regulatory documents or submissions
- Coordinates, prepare, or review regulatory submissions for regulatory compliance
- Identifies relevant regulatory guidance documents, national and international standards
- Interprets regulatory rules or rule changes and ensure that they are communicated new or updated standard operating procedures, work instructions, or policies, in reference to regulatory requirements, corporate policies and procedures to CCL and Cleveland Main campus
- Communicates with regulatory agencies regarding pre-submission information, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
- Advises project teams on regulatory and compliance issues and considerations
- Compiles and maintains regulatory documentation databases or systems
9
Experience For Chief Information Officer Regulatory Lead Resume
- Participates in internal or external audits
- Prepares or direct the preparation of additional information or responses as requested by regulatory agencies
- Reviews clinical protocols to ensure collection of data needed for regulatory submissions
- Supports regulatory inspections and provide pre-inspection data as requested in conjunction with the Governance Team and post-inspection follow-up information as requested
- Develops/tracks regulatory quality metrics
- Supports the Head of Quality & Integrated Governance with specific Quality Improvement projects as directed
10
Experience For VP, Official Risk & Regulatory Lead Resume
- Manage the EMEA Regional Team responsible for managing responses to regulatory, audit, and client requests and monitoring resolution of regulatory and audit findings originating in that region
- Good capability to understand new official requirements and adopt to changes
- Experience in Biotech or Pharmaceutical industry
- Delivery of at least one major application (NDA/BLA/MAA/JNDA etc…), or extensive experience with late stage development/marketed products
- Project management experience, preferably backed-up with a relevant project management qualification (e.g., – PRINCE 2)
List of Typical Skills For a Regulatory Lead Resume
1
Skills For Cib-cfs Complex Change Prod Dev Lead Regulatory Resume
- Project Lead our delivery from estimation to prioritisation, development, testing and implementation
- Develop and maintain an excellent working relationship with all stakeholders (regulators, office and field staff and external partners)
- Experience in technology delivery and support functions
- Proven ability to independently direct the activities of cross-functional teams
- Proficient regulatory experience in the pharmaceutical/biotechnology
- Good knowledge of new business processes and front-to-back operations knowledge
- Highly motivated individual and a strong team leader as well as a collegiate team player who can partner across other functions, regions and businesses
2
Skills For GTI Asia Audit & Regulatory Lead Resume
- Experience in team, people and performance management
- Direct experience in one or more processes for IT auditing, including preparation, engagement, execution, reporting and remediation of findings
- Drive for simplicity, effectiveness and value
- Excellent location and office space
- An environment of highly experienced work colleagues
3
Skills For IT Regulatory Program Lead Resume
- Demonstrates professional confidence in his/her abilities and global understanding of regulatory affairs
- Previous line-management experience is essential
- Regulatory submission experience is required
- Work in a fast-paced environment and reprioritize
- Demonstrable experience with the preparation of regulatory documents or submissions
4
Skills For International Regulatory CMC Liaison Lead Resume
- Coordinating and completing reports required by regulatory authorities
- Working with policies, procedures and SOP’s
- Ensuring compliance with regulations set by the Drug Regulatory Agency
- Inspiring work atmosphere
- Understanding of SPL format and requirements for legacy and PLR labels
- Take a lead role designing and developing solutions to meet requirements gathered on our multi-year, multi-asset programme
- Develops and implement local monitoring systems to ensure compliance with national standards (including CQC)
5
Skills For Global Regulatory Lead-development Products Resume
- Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents
- Facilitate the execution of all regulatory permitting initiatives for all operating areas
- Responsible for development of plans, content, timing, execution of all US FDA submissions
- Collaborates with global Regulatory CMC and Labeling subteam representatives to ensure comprehensive support for US submission activities
- Maintains expert knowledge of evolving US regulations, FDA initiatives, ODAC outcomes and concerns
- Opportunity to be a part of rapidly expanding and well-known global organization
- Establish and maintain collaborative working relationship with assigned regulatory agencies and other key industry stakeholders
6
Skills For Global Regulatory Lead-neurosciences Resume
- Coordinate and compose time sensitive responses to incoming regulatory and legislative inquiries and issues reflective of compliance with program requirements
- Obtains and distributes updated information regarding national or international laws, guidelines, or standards
- Determines the types of regulatory submissions or internal documentation that are required in situations such as critical incidents, mandatory reporting
- Develops and conducts employee regulatory training in conjunction with the Head of Quality & Integrated Governance
- Label Working Group (LWG)
- Represents the US regulatory position to senior management governance committees as needed
- 4) The GRL advocates and drives the ‘one GRA’ perspective with team stakeholders. The GRL also provides regulatory leadership and perspective into the labeling development and maintenance with the support of the GRAST
7
Skills For Regulatory Labeling Strategy Lead Resume
- Work closely with ORC business, Reg Hub Program Manager, Architect and technology BAs to help Regulatory Hub deliver to its strategic roadmap
- Escalate and report progress, risks and issues to ORC management team
- Work closely alongside the Reg Hub - Procurement team in Pune
- Preferably with 5 years of relevant work experience in either Regulatory Transaction Reporting, Risk and Control or Audit skills and experience on operational processes and controls
- Delivery focus and general ability to pick up information quickly and turn around deliverables under pressure
- Good relationship management and influencing skills to work with a wide spectrum of working partners and at the same time be able to challenge them effectively and collaboratively
- Working with the Land and Legal departments preparing applications for exceptions to Field Rules and/or well spacing requirements
8
Skills For Global Seed Health Regulatory Lead Resume
- Applications for New well drilling permits, completion or recompletion reporting
- Ensure appropriate development, goal setting and performance management for direct reports
- Integrity and discretion are key to help ensure sensitive information is handled with care
- Continuous improvement focus and ability to apply to processes
- Extensive knowledge of state (New Mexico and Texas) and federal Oil and Gas regulations and statutes
- Recent experience working in a corporate Audit, Regulatory, Risk and Controls environment including risk identification, control evaluation, testing, sampling methodologies, audit engagement process, controls substantiation, etc
- IT Risk regulatory and corporate requirements such as SOX, SSAE16, AAF, PCI-DSS etc
- Exposure to IT Risk controls frameworks: COSO, COBIT, NIST, Cybersecurity Horizontal reviews
9
Skills For Chief Information Officer Regulatory Lead Resume
- File required reports to oil & gas regulatory agencies in a timely manner, including the Bureau of Land Management, US Fish & Wildlife, Texas Railroad Commission, the New Mexico Oil Conservation Commission and the Colorado Oil & Gas Conservation Commission, as well as district, county or municipal agencies
- Responding to notices of potential non-compliance to ensure timely resolution
- Provide advice to other Oxy departments regarding oil and gas field development to efficiently comply with regulatory requirements
- Coordinate agency hearings with appropriate representatives
- Work closely with Oxy regulatory advocacy, governmental and public affairs departments to protect the company’s reputation and ability to efficiently implement development projects
- Participate in due diligence reviews and facilitate regulatory reporting related to the acquisition and divestiture of properties
- Listens to and carefully considers others’ perspectives, especially to manage and resolve conflict
- Diverse and multinational work environment
10
Skills For VP, Official Risk & Regulatory Lead Resume
- Campus style site, with modern work space
- Self-motivated and organized, with determination to achieve goals
- Experience (min 5-10 years for the Regulatory Lead) in pharmaceutical regulatory affairs working with cross-functional and international teams
- Self-motivated, pro-active and strategically focused
- Lead without direct responsibility
- Strong communication skills, including high-level writing and editing skills, the ability to speak publicly and the ability to explain complex information in a meaningful way
- Train and onboard new team members
- Previous experience of supporting regulatory inspections; e.g., the provision of pre-inspection data as required, in conjunction with the Governance Team and post-inspection follow-up
List of Typical Responsibilities For a Regulatory Lead Resume
1
Responsibilities For Cib-cfs Complex Change Prod Dev Lead Regulatory Resume
- Ensure delivery of activities
- Pharmaceutical experience in Regulatory Affairs working with cross-functional and international teams and with knowledge and experience of regional regulatory procedures and legislation related to two or more of the following: drug development, product registration, line extension or license maintenance
- Pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs (regionally or globally)
- Product registration knowledge
- Global Regulatory Team (GRT)
- Global Development Team (GDT)
- Regulatory CAPA management
2
Responsibilities For GTI Asia Audit & Regulatory Lead Resume
- Clinical Study Team (CST)
- Participate in strategic development planning initiatives with other members of the SERC organization and members of other teams – Asset, Operations, and Land to ensure that regulatory risks, permitting requirements, costs and timeframes are identified, communicated and mitigated
- Coordinate the regulatory training of internal staff and contractors as required
- Participate and assume leadership roles during regulatory seminars, conferences and meetings with local trade organizations such as OKOGA, NDPC, UPA, and WEA
- Communicate and lead advocacy efforts with numerous government agencies such as BLM, BIA, USFWS, UDOGM, and ACE
3
Responsibilities For IT Regulatory Program Lead Resume
- Develop and maintain a regulatory compliance system
- Management of all third-party NEPA projects
- Supervise and mentor regulatory team personnel to ensure compliance with state and federal regulatory and statutory requirements
- 1) REGULATORY COMPLIANCE
- Great benefits scheme
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