CMC Regulatory Affairs Consultant with experience in peptides and oligonucleotides
United States of America, Remote Additional Locations: Canada, Ontario, Remote 职位编号 R0000038475 类别 Consulting关于这个职位
Exceptional opportunity for a highly experienced analytical chemist to partner with a large global biopharmaceutical client and lead regulatory CMC strategy for cutting‑edge peptide and oligonucleotide therapeutics.
In this role, the Regulatory Affairs Senior/Consultant will drive global regulatory strategy and submission activities for complex synthetic and nucleic acid–based products, partnering closely with R&D, CMC, clinical, and quality teams to ensure compliance with international standards and accelerate successful product approvals.
Qualifications & Experience
Educational Background
Bachelor’s or Master’s degree in chemistry, biochemistry, pharmaceutical sciences, or related discipline. Ph.D. in organic chemistry is preferred if possible.
Technical & Regulatory Expertise
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.
Regulatory & Professional Competencies
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.
Desired Skills
Technical Skills
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 Qualifications
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.
Based upon the location of this client partner, candidates located in EST are preferred. Consideration, however, will be given to exceptional candidates in other time zones located in the US and Canada.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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