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Associate Director, Regulatory CMC at Vaxcyte - ApplyBlast

Associate Director, Regulatory CMC

Vaxcyte

6 months ago

3.9 on Glassdoor

Remote

Full Time

Senior

0 applicants

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About this role

A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development.

Responsibilities

Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies
Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance
Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
Provides CMC regulatory guidance to cross-functional teams and key stakeholders
Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development

Skills

Qualifications

Bachelor’s Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices)Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experiencePrior experience preparing/authoring CMC DS sections (BLA, Post-approval supplements/variations, INDs/IMPDs)

About Vaxcyte

vaxcyte.com

Headquarters

San Carlos, California, United States

Company Size

51-200 employees

Founded

2013

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Vaxcyte is a clinical-stage vaccine innovation company dedicated to eliminating bacterial infections — including invasive pneumococcal disease, Group A Strep, and Shigella — using advanced chemistry and a proprietary cell-free protein synthesis platform. Its lead programs, VAX-31 (a 31-valent PCV) and VAX-24 (a 24-valent PCV), are being evaluated in Phase 3 trials for the prevention of invasive pneumococcal disease, with additional early-stage candidates targeting Group A Strep and Shigella. Vaxcyte is also investing up to $1 billion in U.S. biomanufacturing expansion to support scalable vaccine production.