Homeoffice Associate Director, Regulatory Support for Global ASAT at Vaxcyte
Vaxcyte · San Carlos, United States Of America · Remote
- Senior
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Summary:
As we grow, we are seeking a strategic and collaborative Associate Director, Regulatory Support for Global ASAT (Analytical Sciences and Technology) to manage and support all activities associated with the analytical aspects of regulatory CMC related support.
The Associate Director, Regulatory Support will manage the timelines and deliverables to ensure submission requests are aligned with project milestones, and ensure that all the sections are complete, well-written, and meet all relevant requirements. This role is instrumental in ensuring scientific data integrity, regulatory readiness, and the preservation of institutional knowledge in a dynamic, fast-paced clinical environment.
Essential Functions:
- Plan and prepare analytical sections for global regulatory CMC-related content pertaining to Marketing Application (new and renewals), Post-approval Variations, and periodic reports for North America and International markets in accordance with the developed regulatory strategy.
- Collaborate and align with Reg CMC Product Lead regarding change record assessments of proposed analytical changes and regulatory strategy, provide regulatory guidance for support of implementation to cross-functional stakeholders.
- Ensure required analytical regulatory documents for submissions are complete, accurate, and meet relevant requirements.
- Manage the timelines and deliverables to ensure analytical submissions are aligned with program milestones and assure that regulatory query timelines are met.
- Proactively identify issues and escalate to Global Analytical and Reg CMC Product Lead.
- Develop relationships with Analytical Development, QC, Regulatory Affairs, Technical Development, Sites (internal and external), and Quality to support submission preparation.
- Process documentation requests for ASAT to support key application activities and queries.
- Assist with data/documentation gathering for regulatory authority (FDA, Health Canada) interactions for assigned projects such as pre-Agency meeting requests, briefing packages.
- Managing and/or assisting in responding to country health authority queries.
- Work in Regulatory and Quality databases via Veeva platform.
Requirements:
- Degree(s) in Life Sciences, Data Science, Information Management, or related discipline with a minimum of 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A. Other combinations of education and/or experience may be considered.
- Proven experience leading enterprise data governance and knowledge sharing initiatives in a highly regulated environment.
- Strong project management and communication skills; able to work cross-functionally with scientific and operational teams.
- Experience with tools like LIMS, SharePoint, Veeva Vault, Confluence, Tableau, and SQL is highly desirable.
- Experience supporting clinical trials and regulatory submissions (e.g., IND, BLA) preferred.
- Background in immunology, vaccines, or infectious disease R&D preferred.
- Experience in scaling systems and processes in a high-growth, early- to mid-stage biotech company preferred.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
