Senior Manager, Regulatory Affairs

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the Regulatory Affairs representative in various internal cross-functional project teams, improvement initiatives, and provide regulatory insights on diverse CMC-related topics.

• Oversee the gathering, assessment, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining thorough trackers for documentation requests and timelines.

• Manage the development of responses to inquiries from regulatory authorities.

• Ensure adherence to commitments made with various regulatory agencies.

• Collaborate with cross-functional project teams and external business partners to formulate regulatory strategies and pinpoint regulatory risks.

• Supervise the coordination, preparation, and prompt submission of regulatory documents and filings.

• Review and sanction change controls related to proposed product/process modifications and evaluate their impact concerning regulatory requirements.

• Foster constructive working relationships with the Regulatory team and other departments.

• Coordinate responses to CMC-related inquiries from Health Authorities.

⛳️ Requirements

• Bachelor of Science in a scientific field (Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics, or Medical Devices).

• Over 9 years of experience in the vaccine or biotech industry, or a related field, or a comparable combination of education and experience.

• Previous experience in preparing/authoring CMC DS sections:

• BLA is highly preferred.

• IND is highly preferred.

• IMPD.

• Previous development or manufacturing experience is beneficial.

• Familiarity with module 32S and 32P.

• Proficient in computer software (LIMS, SAP, TrackWise, Veeva will be utilized).

• Capable of meeting multiple deadlines across various projects/programs with a high level of accuracy and efficiency.

• Demonstrates a thorough understanding of how their discipline integrates within the function and recognizes its contribution to Vaxcyte’s achievement of business objectives.

🏝️ Benefits

• The compensation package will be competitive and includes comprehensive benefits along with an equity component.