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Associate Director, Regulatory Support for Global ASAT

San Carlos, California, United States

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. 
 
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
 
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
 
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
 
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
 
*MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

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.
Reports to: Senior Director, Global Analytical Sciences and Technology (ASAT) Lead
 
Location: San Carlos, CA; Open to remote
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $173,000 - $201,000 (SF Bay Area). Salary ranges for non-California locations may vary.

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.

 

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