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$137.6K

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How much do associate director regulatory affairs cmc jobs pay per year?

As of Sep 7, 2026, the average yearly pay for associate director regulatory affairs cmc in the United States is $137,563.00, according to ZipRecruiter salary data. Most workers in this role earn between $110,000.00 and $174,000.00 per year, depending on experience, location, and employer.

What does an associate director regulatory affairs CMC do?

An Associate Director Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) oversees the regulatory aspects of product development and manufacturing for pharmaceuticals or biotechnology products. They are responsible for ensuring that all CMC documentation complies with global regulatory requirements and is submitted accurately and on time to health authorities. Their role involves collaborating with cross-functional teams to support product approvals, lifecycle management, and post-approval changes. They also provide strategic guidance on regulatory pathways and help resolve regulatory issues related to manufacturing and product quality.

What are the main challenges an associate director regulatory affairs CMC typically faces when managing regulatory submissions?

An Associate Director Regulatory Affairs CMC often encounters challenges such as navigating evolving global regulatory requirements, aligning cross-functional teams (like R&D, Quality, and Manufacturing), and ensuring timely delivery of high-quality Chemistry, Manufacturing, and Controls (CMC) documentation. Balancing multiple projects and managing tight timelines while responding to regulatory agency queries requires strong project management and communication skills. Staying updated on changes in regulations and proactively addressing potential compliance issues is also critical in this role.

What are the key skills and qualifications needed to thrive as an associate director regulatory affairs CMC, and why are they important?

To thrive as an Associate Director Regulatory Affairs CMC, you need extensive knowledge of chemistry, manufacturing, and controls (CMC) regulations, along with a relevant scientific degree and experience in regulatory submissions. Familiarity with regulatory submission platforms (e.g., eCTD), document management systems, and global regulatory guidelines is essential. Strong leadership, strategic thinking, and clear communication are vital soft skills for managing cross-functional teams and ensuring compliance. These skills ensure effective regulatory filings, smooth product development, and successful global market access for pharmaceutical products.
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Associate Director Regulatory Affairs Cmc jobs near you
Infographic showing various Associate Director Regulatory Affairs Cmc job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 70% Full Time, 27% Part Time, 1% Temporary, and 1% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $137,563 per year, or $66.1 per hour.

Global CMC Regulatory Affairs Director (Assoc/Dir) (Bothell)

Doist

Bothell, WA • On-site

Full-time

Re-posted 2 days ago

Job description

Immunome, Inc. seeks an Associate Director / Director, Regulatory Affairs CMC to lead global regulatory CMC strategies across modalities. You will manage key deliverables and ensure alignment with accelerated submission timetables, while communicating with global health authorities.

This role reports to the Senior Director, Regulatory Affairs CMC and partners with Technical Operations, QA, Supply Chain, and Project Management to ensure regulatory compliance and timely filings.

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