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Regulatory CMC Lead - Peptide & Oligo Therapeutics

Parexel International, Albany, New York, United States

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A global biopharmaceutical company seeks a highly experienced analytical chemist to lead regulatory CMC strategy for peptide and oligonucleotide therapeutics. The Regulatory Affairs Senior/Consultant will be responsible for driving global regulatory strategy and submissions, working closely with R&D, CMC, and quality teams. Candidates should have 4-7 years of experience in synthesis and testing, and a Bachelor’s or Master’s degree, with a Ph.D. preferred. Familiarity with FDA and ICH standards is crucial, and applicants should be located in EST or nearby regions within the US and Canada. #J-18808-Ljbffr