CMC Regulatory Affairs Consultant, Peptides and Oligonucleotides

Job Description: • Partner with a large global biopharmaceutical client and lead regulatory CMC strategy for peptide and oligonucleotide therapeutics • Drive global regulatory strategy and submission activities for complex synthetic and nucleic acid–based products • Collaborate closely with R&D, CMC, clinical, and quality teams to ensure compliance with international standards and accelerate successful product approvals Requirements: • Bachelor’s or Master’s degree in chemistry, biochemistry, pharmaceutical sciences, or related discipline • Ph.D. in organic chemistry is preferred if possible • 4-7 years in peptide or oligonucleotide synthesis, purification, and analytical testing (HPLC, LC-MS, NMR) • Hands-on experience with solid-phase synthesis or phosphoramidite-based workflows • Familiarity with purity, identity, sequence confirmation, and impurity profiling requirements per FDA/ICH/USP standards • Strong understanding of regulatory requirements for synthetic peptides and oligonucleotides • Proven track record preparing CMC documents and regulatory submissions • Proficiency in chromatography (HPLC/UPLC), LC-MS, UV‑Vis, NMR, and sequence confirmation tools • Experience with automated or scale‑up synthesis platforms, lab instruments, and LIMS/electronic lab notebooks • Experience with conjugation strategies (e.g., peptide-oligo, ligand-oligo constructs) • Knowledge of global regulations (FDA, EMA, ICH) for biologics and oligo therapeutics • Process development or GMP exposure in peptide/oligo manufacturing settings Benefits: • Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options