CMC Regulatory Affairs Consultant with experience in ...

Exceptional opportunity for a highly experienced analytical chemist to partner with a large global biopharmaceutical client and lead regulatory CMC strategy for cuttingu2011edge 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 acidu2013based 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 + Bacheloru2019s or Masteru2019s 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, UVu2011Vis, NMR, and sequence confirmation tools. + Experience with automated or scaleu2011up 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. #LI-LB1 #LI-REMOTEEEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Created: 2026-02-05