VP / SVP Regulatory Affairs
Location : San Francisco, CA
6-12 month-intital contract
Key Responsibilities :
- Develop and execute global regulatory strategies across nonclinical, clinical, quality, and CMC functions ensuring alignment with corporate objectives / timelines and regulatory compliance.
- Provide advice and guidance to project teams on the interpretation and application of relevant regulatory guidances and requirements, and review processes.
- Present regulatory strategies and issues at team and governance meetings.
- Play a key role in planning, preparation, drafting, and review of regulatory documentation, including IND / CTA / GMO / BLA / MAA submissions, regulatory interactions, and responses to queries from competent authorities as required for the investigation and registration of drugs in the US and ex-US countries.
- Serve as the primary health authority contact for assigned projects and foster positive and effective working relationships between project team members and health authority reviewers.
- Collaborate cross-functionally with nonclinical, CMC, and quality leadership and stakeholders on planning and coordinating regulatory submissions and interactions with health authorities.
- Prepare teams for and lead health authority meetings.
- Manage and participate in the creation, review, assembly, and submission of regulatory documentation, including INDs, CTAs, and amendments, and annual reports.
- Ensure consistency, completeness, and adherence to standards for all regulatory submissions.
- Provide regulatory review and impact / implementation assessment of proposed Change Control records and manage the associated regulatory notifications.
Required Skills and Background :
- Minimum 12 years of relevant regulatory leadership experience in the biotech and pharmaceutical industry
- Proven track record supporting CTD format and content for regulatory filings (e.g., INDs, CTAs, NDAs / BLAs).
- Experience in establishing regulatory capabilities and functions.
- Demonstrated ability to develop and maintain excellent working relationships with EU regulatory agencies, US FDA, and similar key international regulatory agencies, including the planning / implementation of agency meetings.
- Excellent interpersonal communication and presentation skills to facilitate collaboration across functions and build successful relationships with internal and external stakeholders, as well as external parties.
- Experience managing complex schedules and shifting priorities in a dynamic environment.
- Ability to dissect complex issues in the gene editing and gene therapy field and quickly distill key items for discussion with regulatory authorities and guide teams in the preparation of responses to regulatory questions.
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