Prin. Scientist, (Director) Regulatory Affairs-CMC

Merck · Rahway, NJ +1 more

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RegulatoryFull-time$191k–$300kCompany career page

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Role summary

Principal Scientist in Regulatory Affairs leading CMC strategy development and global regulatory submissions for pharmaceutical products. Responsible for managing CMC documentation, directing regulatory discussions with agencies, and overseeing a matrixed team of regulatory professionals on small molecule and peptide programs.

What they're looking for

Bachelor's degree in biological science, engineering, pharmacy, chemical engineering, biology, microbiology, or biochemistry; advanced degree preferred
5–10 years pharmaceutical development experience in research, manufacturing, testing, or regulatory CMC
At least 7 years regulatory CMC experience leading NDA/MAA CTD preparation
Strong technical understanding of manufacturing, process development, analytical, and quality assurance
Proficiency in English; additional language skills a plus
Demonstrated ability to critically review scientific data and assess technical arguments
Superior written and oral communication skills in multicultural environments

What you'll be doing

Serve as CMC Product Lead for small molecule and peptide programs, accountable for regulatory milestones and success probability assessment
Lead regulatory CMC interactions with agencies and facilitate review and approval of submissions
Direct regulatory CMC strategy and team oversight across global applications, including IND/CTA and marketing submissions
Manage CMC documentation execution and coordinate responses to health authority questions
Identify and escalate regulatory issues; develop talent and succession planning within team

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