Senior Manager, Regulatory Affairs

Vaxcyte

Hands-on role providing both strategic and operational activities in global regulatory CMC strategies. Managing regulatory submissions and interactions with Health Authorities at Vaxcyte.

Posted 6/16/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $183,000 - $194,000 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

regulatory CMC submissionsBLAINDIMPDmodule 32Smodule 32Pdocumentation preparationchange control reviewregulatory strategy developmentregulatory risk identification

Soft Skills

collaborationrelationship buildingtime managementaccuracyefficiencycross-functional teamworkcommunicationproblem-solvingorganizational skillsadaptability

Tools & Technologies

LIMSSAPTrackWiseVeeva

Industry Keywords

vaccine industrybiotech industryregulatory affairsCMCHealth Authoritiesscientific disciplineBiologyChemistryPharmacymedical devices

About the role

Key responsibilities & impact

Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics.
Manage the collection, review, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining comprehensive trackers for documentation requests and timelines.
Manage preparation of responses to queries from regulatory authorities.
Ensure conformance to commitments made with various regulatory agencies.
Collaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks.
Manage coordination, preparation, and timely submission of regulatory documents and filings.
Review and approve change controls related to proposed product/process changes and assess their impact against regulatory requirements.
Cultivate productive working relationships with the Regulatory team and other departments.
Coordinate responses to CMC-related queries from Health Authorities.

Requirements

What you’ll need

Bachelor of Science in a scientific discipline (Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices).
9+ years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience.
Prior experience preparing/authoring CMC DS sections:
BLA highly preferred.
IND highly preferred.
IMPD.
Prior development or manufacturing experience is a plus.
Experience with module 32S and 32P.
Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Vaxcyte’s achievement of business objectives.

Benefits

Comp & perks

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