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Cmc Regulatory Affairs Jobs (NOW HIRING)

Gilead

Manager, Regulatory Affairs CMC

Foster City, CA · On-site

$146K - $189K/yr

The CMC Regulatory Affairs Manager is responsible forsupporting the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs. This role ...

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Cmc Regulatory Affairs information

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$145

How much do cmc regulatory affairs jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for cmc regulatory affairs in the United States is $34.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $26.20 per hour, depending on experience, location, and employer.

What is a CMC Regulatory Affairs?

A CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs job involves ensuring that pharmaceutical and biotech products meet regulatory requirements for their manufacturing processes, quality control, and formulation. Professionals in this role prepare and submit regulatory documents, liaise with health authorities, and support compliance throughout the product lifecycle. They work closely with cross-functional teams, including R&D, quality assurance, and supply chain, to ensure regulatory approval and product availability. Their expertise helps maintain compliance with global regulations from agencies like the FDA, EMA, and other regulatory bodies.

What are the typical daily responsibilities for a CMC Regulatory Affairs professional?

A CMC Regulatory Affairs professional typically prepares, reviews, and manages regulatory submissions related to the chemistry, manufacturing, and controls sections of pharmaceutical products. Daily tasks include coordinating with cross-functional teams such as manufacturing, quality assurance, and R&D to gather required documentation and data, as well as ensuring compliance with evolving regulatory requirements. You may also interact with regulatory authorities, address technical or compliance questions, and support post-approval activities like product changes or renewals. This role requires managing multiple projects simultaneously while maintaining accuracy and adherence to deadlines, making it both dynamic and integral to a product’s development lifecycle.

What are the key skills and qualifications needed to thrive in the CMC Regulatory Affairs position, and why are they important?

To thrive as a CMC Regulatory Affairs professional, you need a solid background in pharmaceutical sciences or related fields, experience with global regulatory submissions (e.g., IND, NDA, BLA), and a strong understanding of Chemistry, Manufacturing, and Controls (CMC) requirements. Familiarity with regulatory databases, document management systems, and up-to-date knowledge of regional and international regulatory guidelines (such as ICH, FDA, and EMA regulations) is essential. Strong organizational skills, meticulous attention to detail, and effective communication abilities are highly valued soft skills. These competencies enable successful navigation of complex regulatory landscapes, ensure timely product approvals, and promote cross-functional collaboration within development teams.

Is regulatory affairs high paying?

Regulatory affairs professionals, including those in CMC Regulatory Affairs, often earn competitive salaries that vary by experience, location, and industry sector. Senior roles with specialized knowledge and certifications tend to have higher compensation, reflecting the importance of compliance and regulatory expertise in the pharmaceutical and biotech industries.
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Cmc Regulatory Affairs jobs near you
Infographic showing various Cmc Regulatory Affairs job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 9% Part Time, and 2% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.

Director - CMC Regulatory Affairs (Gene Therapy)

Stark Pharma Solutions Inc

Piscataway, NJ • Remote

$153K - $202K/yr

Contractor

Re-posted 3 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