Remote Global Regulatory CMC Lead - Vaccines

Regulatory Jobs; San Carlos (CA); Remote; USD 183.000 - 194.000; Vollzeit

Benefits dieser Stelle

Equity

Comprehensive benefits

Zusammenfassung

Vaxcyte is seeking a senior regulatory affairs professional to lead global CMC strategies for multi-product investigational vaccines. You will manage CMC submissions, interact with Health Authorities, and guide cross-functional teams to meet global regulatory requirements.

This remote US-based role includes equity and comprehensive benefits. The position reports to the Executive Director, Regulatory CMC and requires 9+ years in vaccine/biotech regulatory work, with DS/DS-IND and module 3.2S/3.2P

Qualifikationen

• Bachelor degree in a scientific discipline as listed (Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs/Biologics/Medical Devices).
• 9+ years of experience in vaccine or biotech regulatory affairs or related field.
• Experience preparing/authoring CMC DS sections (BLA/IND highly preferred; IMPD).
• Experience with module 3.2S and 3.2P; development or manufacturing experience is a plus.

Aufgaben

• Represent Regulatory Affairs in internal cross-functional teams and provide regulatory positions on CMC topics.
• Coordinate documentation for regulatory CMC submissions with trackers for requests and timelines.
• Prepare responses to regulatory authorities' queries.
• Ensure conformance to regulatory commitments with agencies.
• Collaborate to develop regulatory strategies and identify risks.

Kenntnisse

Regulatory strategy

Cross-functional collaboration

Ausbildung

Bachelor of Science in a scientific discipline

Tools

LIMS

SAP

TrackWise

Veeva

Jobbeschreibung

Vaxcyte is seeking a senior regulatory affairs professional to lead global CMC strategies for multi-product investigational vaccines. You will manage CMC submissions, interact with Health Authorities, and guide cross-functional teams to meet global regulatory requirements.

This remote US-based role includes equity and comprehensive benefits. The position reports to the Executive Director, Regulatory CMC and requires 9+ years in vaccine/biotech regulatory work, with DS/DS-IND and module 3.2S/3.2P