[Remote] CMC Regulatory Affairs Consultant with experience in peptides and oligonucleotides
Note: The job is a remote job and is open to candidates in USA. Parexel is a global biopharmaceutical consulting company seeking a highly experienced analytical chemist to lead regulatory CMC strategy for peptide and oligonucleotide therapeutics. The Regulatory Affairs Senior/Consultant will drive global regulatory strategy and submission activities, collaborating with R&D, CMC, clinical, and quality teams to ensure compliance and accelerate product approvals.
Responsibilities
- Drive global regulatory strategy and submission activities for complex synthetic and nucleic acid–based products
- Partner closely with R&D, CMC, clinical, and quality teams to ensure compliance with international standards
- Prepare CMC documents and regulatory submissions
- Analyze guidelines and precedents regarding regulatory requirements for synthetic peptides and oligonucleotides
Skills
- Bachelor's or Master's degree in chemistry, biochemistry, pharmaceutical sciences, or related discipline
- 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 and ability to analyze guidelines and precedents
- Proven track record preparing CMC documents and regulatory submissions
- Analytical, well-organized, and able to work across functions to resolve technical or compliance issues
- 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
- Ph.D. in organic chemistry
- 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
- Candidates located in EST are preferred
Company Overview
- Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. It was founded in 1983, and is headquartered in Raleigh, North Carolina, US, with a workforce of 10001+ employees. Its website is
Company H1B Sponsorship
- Parexel has a track record of offering H1B sponsorships, with 33 in 2025, 46 in 2024, 41 in 2023, 51 in 2022, 54 in 2021, 33 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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