Senior Manager, Medical/Regulatory Writer

Role: Senior Manager, Medical/Regulatory Writer responsible for leading and coordinating medical and scientific regulatory documentation for cell therapy programs from first-in-human trials to product registration. Responsibilities: authoring and supervising regulatory documents including protocols, clinical study reports, summaries, briefing documents, and responses to health authority inquiries; ensuring compliance with global regulatory standards; managing external writers to maintain messaging consistency; supporting development of submission strategies and contributing to procedural best practices; overseeing document quality control and archiving. Requirements: BS with 4-7 years’ regulatory writing experience or advanced degree (MS, PharmD, Ph.D., M.D.) with 3-5 years in biopharma; 7-10 years industry experience, ideally supporting biologics or cell/gene therapies; proficiency in MS Word, Adobe Acrobat, and document management systems; understanding of global regulatory requirements and clinical development processes. Preferred: experience with umbrella/basket trials, RFI responses, electronic submission systems, and review platforms. HighValue: biologics, cell/gene modalities; early to late-stage clinical development; global regulatory environment; cross-functional interaction with clinical, preclinical, medical affairs, and regulatory teams. Location: Gaithersburg, MD, Radnor, PA, or remote; no specific travel mentioned.