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Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

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As of Sep 1, 2026, the average hourly pay for remote work from home cmc regulatory in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.
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Infographic showing various Remote Work From Home Cmc Regulatory job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 17% Part Time, and 3% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Associate Director, Regulatory CMC

Vaxcyte

San Carlos, CA • On-site, Remote

$180K - $210K/yr

Full-time

Re-posted 6 days ago

Job description

Summary:

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. Conducts routine regulatory surveillance and communicates new/changing regulations.  

Essential Functions:

  • 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
  • Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
  • Represents company in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
  • Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
  • Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise

Requirements:

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 experience. Other combinations of education and/or experience may be considered.

  • Prior experience preparing/authoring CMC DS sections:
    • BLA highly preferred.
    • Post-approval supplements/variations highly preferred.
    • INDs/IMPDs.
  • Prior development or manufacturing experience is a plus.
  • 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.
  • Excellent interpersonal skills to communicate difficult concepts.
  • Strategic thinking and strong problem-solving skills
  • Collaborates and communicates in an open, clear, complete, timely, and consistent manner
  • Strong sense of planning and prioritization, and the ability to work with all levels of management
  • Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines
Reports to: Executive Director, CMC Regulatory
 
Location: San Carlos, CA / US Remote
 
Work Arrangement: Remote
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $180,000 - $210,500 (SF Bay Area). Salary ranges for non-California locations may vary.
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About Vaxcyte

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

San Carlos, CA, US

Year founded

2013

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