Senior CMC Regulatory Sciences Specialist

Job Overview We are seeking a highly motivated and experienced CMC Regulatory Sciences Specialist to join our dynamic team. This role will involve managing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies across clinical and commercial phases, ensuring compliance with US and international regulatory requirements. The ideal candidate will possess strong technical writing skills, a proactive approach, and the ability to work collaboratively with cross‑functional teams. Responsibilities Develop and execute CMC regulatory strategies for clinical trial applications, amendments, commercial submissions, and marketing applications globally. Prepare and oversee coordination and compilation of CMC dossiers, including Module 3: Quality, ensuring alignment with applicable regulations and guidelines. Author, review and finalize CMC documents and responses to inquiries from global health agencies, maintaining submission timelines. Develop submission strategies, including timelines, approaches, and defining deliverables, while maintaining clear communication with stakeholders. Stay informed on regulatory trends, agency feedback, and global best practices, updating submission processes accordingly. Collaborate with cross‑functional teams and external partners to ensure alignment between regulatory submissions and product supply plans. Engage with regulatory authorities as needed to support CMC‑related modules and submissions. Qualifications Experience in regulatory or technical writing (non‑SOP related) or pharmaceutical development documentation. Strong knowledge of CMC regulatory requirements, FDA regulations, ICH guidelines, and Current Good Manufacturing Practices. Experience managing CMC submissions for clinical and commercial phases preferred. Excellent written and verbal communication skills, particularly in technical writing. Strong project management, critical thinking, and problem‑solving skills. Ability to work independently and within a team, adapting to shifting priorities and strategies. Experience & Education Senior CMC Regulatory Sciences Specialist: 5 years of relevant experience. Principal CMC Regulatory Sciences Specialist: 8 years of relevant experience in a biopharmaceutical/CMC regulatory or industry setting. Advanced degree preferred (MS or PhD). Equivalent combination of education and experience may be considered. The level is determined based on qualifications relevant to the role. BS/BA degree in a scientific discipline required. Salary Range (annually) $78,700.00 – $150,600.00 Benefits Benefits may include health and wellness programs (medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. Equal Opportunity Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveller community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation for known disabilities or chronic illnesses of qualified applicants unless the accommodation would impose undue hardship on the operation of the business. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc