A CMC Regulatory Affairs Coordinator supports the chemistry, manufacturing, and controls portion of pharmaceutical regulatory submissions at an entry level — coordinating across manufacturing, quality, and clinical teams while building the technical fluency the senior CMC role demands.
Most days can involve coordinating CMC document collection from manufacturing and quality teams, supporting senior managers in drafting CMC sections of regulatory submissions like INDs, NDAs, and supplements, tracking commitments, and learning the FDA, EMA, and other agency requirements that govern CMC work. You're often the operational hub that keeps technical inputs flowing.
The hardest parts often involve the technical complexity of CMC science — chemistry, formulation, analytical methods, process controls — and the cross-functional coordination demands. Manufacturing, quality, analytical development, and regulatory all need to work in concert; junior coordinators learn to bridge technical languages across disciplines. Variance between small biotech and large pharma operations is significant.
People who tend to thrive here are scientifically grounded, organized, and comfortable bridging technical disciplines. If you want pure bench science or strategic regulatory work, the coordinator role can feel operational. If you find satisfaction in supporting the regulatory mechanics that move drugs through approval, the entry-level role launches careers in CMC regulatory affairs, quality, or broader regulatory strategy.
Where this role sits in the broader career landscape — and where it can take you.
Roles like this one sit within a broader occupational category. The numbers below reflect that full landscape — helpful for context, but your specific experience will depend on level, specialty, and where you work.
A CMC Regulatory Affairs Coordinator supports the chemistry, manufacturing, and controls portion of pharmaceutical regulatory submissions at an entry level — coordinating across manufacturing, quality, and clinical teams while building the technical fluency the senior CMC role demands.
Median pay for a Cmc Regulatory Affairs Manager (chemistry, Manufacturing And Controls Regulatory Affairs Manager) Coordinator is about $137K nationally, with the field ranging roughly from $69K to $228K depending on experience, employer, and metro (BLS).
Core skills for this role include Writing, Reading Comprehension, Active Listening, Speaking, and Critical Thinking.
Most people in this role hold a bachelor's degree.
Employment in this field is projected to grow about 4.5% through 2034, with roughly 630,980 people working in it today (BLS).
Closely related roles include CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager), Compliance Director, and Regulatory Manager.
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