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Director Cmc Regulatory Jobs (NOW HIRING)

Recursion

Director, CMC Regulatory Affairs

New York, NY · Remote

$207K - $255K/yr

The Team You'll Join As Director CMC Regulatory Affairs, you will be an essential member of the Recursion Development Team, reporting to the Vice President of Regulatory Affairs. The Development Team ...

Recursion

Director, CMC Regulatory Affairs

New York, NY · On-site

$207K - $255K/yr

The Team You'll Join As Director CMC Regulatory Affairs, you will be an essential member of the Recursion Development Team, reporting to the Vice President of Regulatory Affairs. The Development Team ...

Regeneron Pharmaceuticals

$156K - $207K/yr

We are seeking a Director to join our Regulatory Sciences team, leading the development and execution of global CMC regulatory strategies across all Regeneron modalities and product lifecycle stages.

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$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 ...

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How much do director cmc regulatory jobs pay per year?

As of Jul 29, 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.

How much does a director of regulatory affairs make at Abbott?

A Director of Regulatory Affairs at Abbott typically earns between $150,000 and $200,000 annually, depending on experience and location. This role involves overseeing regulatory compliance, preparing submissions, and ensuring product approvals in a highly regulated industry.

What is a Director CMC Regulatory job?

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 in the Director Cmc Regulatory position, and why are they important?

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.

How much does a director of regulatory affairs make in the US?

A director of regulatory affairs in the US typically earns between $130,000 and $180,000 annually, with total compensation often including bonuses and benefits. Salaries vary based on experience, industry, company size, and location, and the role usually requires strong knowledge of regulatory compliance and relevant certifications.

What are some typical challenges faced by a Director Cmc Regulatory, and how can the role overcome them?

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.

What does regulatory CMC do?

A Regulatory CMC (Chemistry, Manufacturing, and Controls) professional ensures that the manufacturing processes, quality controls, and documentation for pharmaceutical products meet regulatory standards. They prepare and review submissions to agencies like the FDA or EMA, ensuring compliance throughout product development and commercialization. Strong knowledge of regulatory guidelines, quality systems, and documentation management is essential in this role.

What is the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs are typically senior executive positions such as Vice President or Director of Regulatory Affairs, with salaries often exceeding $150,000 annually. These roles require extensive experience, leadership skills, and often involve overseeing global regulatory strategies and compliance for large organizations.
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Director Cmc Regulatory jobs near you
Infographic showing various Director Cmc Regulatory job openings in the United States as of July 2026, with employment types broken down into 2% Locum Tenens, 7% Internship, 74% Full Time, 12% Part Time, 2% Contract, and 3% Summer. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $176,150 per year, or $84.7 per hour.

Director - CMC Regulatory Affairs (Gene Therapy)

Stark Pharma Solutions Inc

Piscataway, NJ • Remote

$153K - $202K/yr

Contractor

Posted 28 days ago

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Director – CMC Regulatory Affairs position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Role: Director – CMC Regulatory Affairs (Gene Therapy)

Location: Remote (Anywhere in the U.S.)
 

We're looking for an experienced Director – CMC Regulatory Affairs to join a well-funded, mid-sized Gene Therapy Biotech organization with a strong pipeline and proven success.

Key Responsibilities

  • Lead CMC Regulatory Affairs strategy for gene therapy programs.
  • Author and review CMC sections for regulatory submissions (INDs, BLAs, amendments, and global filings).
  • Collaborate with CMC, Manufacturing, Quality, and Regulatory teams to ensure compliant submissions.
  • Support interactions with regulatory agencies and drive submission readiness.
  • Provide strategic regulatory guidance throughout product development and commercialization.

Required Qualifications

  • Extensive experience in CMC Regulatory Affairs within the biotechnology or pharmaceutical industry.
  • Hands-on experience authoring CMC regulatory content (not just reviewing submissions).
  • Strong knowledge of FDA and global regulatory requirements for biologics/gene therapy products.
  • Experience supporting INDs, BLAs, and other regulatory submissions.
  • Excellent communication, leadership, and cross-functional collaboration skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com