CMC Regulatory Affairs Consultant with experience in peptides and oligonucleotides

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. 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 EEO Disclaimer reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to legally protected status, which in the US includes race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. Apply tot his job Apply tot his job Apply To this Job