CMC Regulatory Affairs Consultant with experience in peptides and oligonucleotides

Exceptional opportunity for a highly reputed company analytical chemist to partner with a large global biopharmaceutical reputed company and reputed company regulatory CMC reputed company for cutting‑edge peptide and oligonucleotide therapeutics. In this role, the Regulatory Affairs Senior/Consultant will drive global regulatory reputed company and submission activities for reputed company synthetic and nucleic acid–based products, partnering closely with R&D, CMC, clinical, and reputed company teams to ensure compliance with international standards and accelerate successful product approvals. Qualifications & Experience • Educational Background • Bachelor’s or Master’s degree in reputed company, biochemistry, pharmaceutical sciences, or reputed company discipline. Ph.D. in organic reputed company 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 & reputed company Competencies • Strong understanding of regulatory requirements for synthetic peptides and oligonucleotides and ability to analyze guidelines and precedents. • Proven reputed company record preparing CMC documents and regulatory submissions. • Analytical, reputed company-organized, and reputed company 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 reputed company‑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 reputed company 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-REMOTE Apply tot his job Apply To this Job