Parexel · 20 hours ago
CMC Regulatory Affairs Consultant with experience in peptides and oligonucleotides
United States
Full-time
Remote
Mid, Senior Level
4+ years expParexel 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.
Pharmaceuticals
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
Qualification
Required
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
Preferred
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
Parexel
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry.
10001+ employees
H1B Sponsorship
Parexel has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (33)
2024 (46)
2023 (41)
2022 (51)
2021 (54)
2020 (33)
Funding
Current Stage
Late StageLeadership Team
Amy France
SVP, CFO - Consulting & Commercial
Carlos Daniel Garcia
VP Chief Financial Officer - Medical Scientific Services Business Unit
Recent News
2024-04-27
2024-04-07
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