Sr. Manager, Regulatory Affairs

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The company focuses on eradicating or treating bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella.

Responsibilities

• Develop and execute multi-product global regulatory CMC strategies for investigational products
• Lead the preparation and filing of regulatory CMC submissions
• Manage interactions with Health Authorities for CMC topics
• Provide regulatory CMC guidance to cross-functional teams
• Manage the collection, review, and coordination of documentation for regulatory CMC submissions
• Manage preparation of responses to queries from regulatory authorities
• Review and approve change controls related to proposed product/process changes
• Ensure conformance to commitments made with various regulatory agencies

Requirements

• Bachelor of Science in a scientific discipline (Biology, Chemistry, Pharmacy, or Regulatory Affairs)
• 9+ years of experience in the vaccine or biotech industry
• Prior experience authoring CMC DS sections (BLA, IND, or IMPD preferred)
• Experience with module 32S and 32P
• Proficiency with LIMS, SAP, TrackWise, or Veeva
• Ability to meet multiple deadlines with high accuracy

Preferred Qualifications

• Prior development or manufacturing experience