CMC Regulatory Affairs Consultant with experience in peptides and oligonucleotides
ParexelJob Description
When our values align, there's no limit to what we can achieve.
Exceptional opportunity for a highly experienced analytical chemist to partner with a large global biopharmaceutical client and lead regulatory CMC strategy for cutting‑edge peptide and oligonucleotide therapeutics.
In this role, the Regulatory Affairs Senior/Consultant will drive global regulatory strategy and submission activities for complex synthetic and nucleic acid–based products, partnering closely with R&D, CMC, clinical, and quality teams to ensure compliance with international standards and accelerate successful product approvals.
Qualifications & Experience
Educational Background
Bachelor’s or Master’s degree in chemistry, biochemistry, pharmaceutical sciences, or related discipline. Ph.D. in organic chemistry is preferred if possible.
Technical & Regulatory Expertise
4-7 years in peptide or oligonucleotide synthesis...
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