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Director Cmc Regulatory Jobs (NOW HIRING)

JobRx, Inc.

$188 - $215/hr

What You'll Do Senior Manager / Associate Director, CMC Regulatory Sciences reports to the head of CMC Regulatory Sciences and will support BridgeBio Pharma and its subsidiaries, including Eidos ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site

$180K - $210K/yr

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 ...

Revolution Medicines

Director, Global CMC Regulatory

$153K - $202K/yr

The Director, Global CMC Regulatory is a strategic leadership role responsible for developing, driving, and executing global commercial CMC regulatory strategies to secure and maintain marketing ...

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How much do director cmc regulatory jobs pay per year?

As of Aug 21, 2026, the average yearly pay for director cmc regulatory in the United States is $176,150.00, according to ZipRecruiter salary data. Most workers in this role earn between $150,000.00 and $198,000.00 per year, depending on experience, location, and employer.

What is a Director CMC Regulatory?

A Director CMC (Chemistry, Manufacturing, and Controls) Regulatory oversees the regulatory strategy for the development, approval, and lifecycle management of pharmaceutical and biologic products. They ensure compliance with global regulations, provide guidance on CMC-related submissions, and collaborate with cross-functional teams to support product development. This role involves working with health authorities, managing regulatory filings, and mitigating potential compliance risks.

What are the key skills and qualifications needed to thrive as a Director CMC Regulatory?

To thrive as a Director Cmc Regulatory, you need an in-depth knowledge of global regulatory requirements for Chemistry, Manufacturing, and Controls (CMC), often supported by an advanced degree in life sciences or pharmacy and extensive regulatory experience. Familiarity with regulatory submission systems (such as eCTD), ICH guidelines, and relevant certification (e.g., RAC) is highly valuable. Exceptional leadership, strategic communication, and cross-functional collaboration skills set successful candidates apart. Mastery of these competencies ensures effective compliance strategies, successful product submissions, and strong relationships with regulatory agencies.

What are some typical challenges faced by a Director CMC Regulatory, and how can they be overcome?

Directors of Cmc Regulatory often navigate complex and constantly evolving global regulations, balancing the need for compliance with the fast pace of product development. Adapting to stringent deadlines, coordinating with cross-functional teams such as R&D, manufacturing, and quality, and managing multiple projects are common challenges. Success in the role requires proactive planning, strong communication, and a deep understanding of regulatory expectations. Leveraging experience and staying updated with industry changes can help mitigate risks and drive successful regulatory submissions.

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Director Cmc Regulatory jobs near you
Infographic showing various Director Cmc Regulatory job openings in the United States as of August 2026, with employment types broken down into 2% As Needed, 86% Full Time, 9% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $176,150 per year, or $84.7 per hour.

Lead CMC Regulatory Affairs for Gene Therapy Programs (Durham)

Atsena

Durham, NC • On-site

$142K - $188K/yr

Full-time

Posted 28 days ago

Job description

Atsena seeks an Associate Director/Director, CMC Regulatory Affairs to lead global regulatory strategy for gene therapy programs from early research to commercialization. The role interfaces with process development, analytical development, manufacturing, and quality to ensure regulatory readiness.

The incumbent will lead CMC sections of INDs/CTAs, BLA/MAA submissions, and annual updates, while coordinating agency interactions with FDA and EMA.

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