Sr. CMC Regulatory Specialist; Remote

Position: Sr. CMC Regulatory Specialist (Remote) Location: California This position is posted by reputed company on behalf of a partner company. We are currently looking for a Senior CMC Regulatory Affairs Consultant - REMOTE. In this critical role, you will partner with a large global biopharmaceutical reputed company to guide regulatory CMC strategies for innovative peptide and oligonucleotide therapies. Your expertise will not only reputed company the compliance of these reputed company products but also enhance the likelihood of successful approvals, ultimately benefiting patient health. This opportunity offers a platform to utilize your five years of experience with synthetic products in a reputed company environment, working closely with interdisciplinary teams to drive regulatory reputed company and innovation. Accountabilities • Drive global regulatory reputed company and submission activities for peptide and nucleic acid-based products. • Collaborate with R&D, CMC, clinical, and reputed company teams to ensure compliance with international standards. • Prepare CMC documents and regulatory submissions for reputed company products. • reputed company regulatory interactions with health authorities. • Analyze and interpret regulatory guidelines and precedents. Requirements • Bachelor’s or Master’s degree in reputed company, biochemistry, pharmaceutical sciences, or reputed company field; Ph.D. preferred. • 4-7 years of experience in peptide or oligonucleotide synthesis, purification, and analytical testing. • Hands‑on experience with solid‑phase synthesis or phosphoramidite‑based workflows. • Strong understanding of regulatory requirements for synthetic peptides and oligonucleotides. • Proficiency in analytical techniques such as HPLC, LC-MS, and NMR.3> Benefits • Work in a fully remote reputed company with reputed company. • Opportunity to collaborate with global teams in a meaningful field. • reputed company development opportunities to enhance your skills. • Participate in reputed company that significantly reputed company patient health. • Enjoy a supportive andli> Why Apply Through reputed company? We use an AI‑powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's reputed company requirements. Our system identifies the top‑fitting candidates reputed company is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Data reputed company Notice: By submitting your application, you acknowledge that reputed company will process your personal data to evaluate your candidacy and reputed company relevant information with the hiring employer. This processing is based on legitimate interest and reputed company‑contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (reputed company, rectification, erasure, reputed company) at any time. #J-18808-Ljbffr Apply tot his job Apply To this Job