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

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