Parexel

CMC Regulatory Affairs Consultant, Peptides and Oligonucleotides

Parexel

full-time

Posted on:

Location Type: Remote

Location: New York • United States

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About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
peptide synthesisoligonucleotide synthesispurificationanalytical testingHPLCLC-MSNMRsolid-phase synthesisphosphoramidite-based workflowsregulatory submissions
Certifications
Bachelor’s degreeMaster’s degreePh.D. in organic chemistry