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Monte Rosa Therapeutics, Inc

Associate Director, Regulatory Affairs – CMC Small Molecules

Basel, Switzerland

  • Lead

About the role

Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of CMC Regulatory Affairs. The CMC Regulatory Affairs will serve as a key regulatory strategist and author for the Chemistry, Manufacturing, and Controls components of Monte Rosa's global regulatory filings. This individual will partner closely with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams to develop CMC regulatory strategy, author and review high-quality submission content (Module 3 and associated summaries), and represent CMC in interactions with health authorities. The role requires strong technical CMC knowledge, regulatory acumen...