you will lead, develop, and implement robust regulatory CMC strategies and provide advice on the development and life cycle... and/or reviewing CMC modules for regulatory submissions for investigational new drugs, clinical trial applications, and meeting...
Job Description The Senior Director, CMC Product Leader, Biologics, will lead CMC functional teams of one or multiple... Development, or Manufacturing at a Director or Senior Director level. Proven track record of successful CMC development...
with Regulatory Affairs, Clinical, Quality, and CMC to ensure submission readiness and compliance. SKILLS Comprehensive... of Regulatory Affairs Operations to join our team. This key leadership role is ideal for a seasoned Regulatory Operations leader who...
, and CMC to ensure alignment and success. Shape the future of regulatory science Stay on the pulse of emerging regulatory...Lead the Future of Regulatory Strategy for Rare Diseases! Are you a strategic regulatory leader ready to shape the...
, and CMC to ensure alignment and success. Shape the future of regulatory science Stay on the pulse of emerging regulatory...Lead the Future of Regulatory Strategy for Rare Diseases! Are you a strategic regulatory leader ready to shape the...
Location: Boston, MA Main responsibilities The Executive Director (ED) Regulatory Science will actively support..., and serve as senior advisor to, the program regulatory teams to define Orchard’s US regulatory strategies across the pipeline...
, and innovative Associate Director specializing in analytical CMC strategy to provide scientific leadership... within and across functional areas. The Associate Director, Analytical CMC Strategy is the primary analytical liaison for their program...
, analytical development, manufacturing science and technology, site QA/QC, and regulatory CMC and commercial functions (i.e., AS&T..., etc.) are used. Support preparation of CMC clinical and commercial regulatory submissions by critically reviewing and approving...
will report directly to the Senior Director, Supply Chain and will be responsible for ensuring that our investigational therapy... with Clinical Operations, CMC, Quality, and Regulatory Affairs to align on assumptions, ensuring robust supply availability...
members, regulatory leads, and senior management in order to advance drug candidates through research and development... and to execute SOWs in a timely fashion. Coordinate with CRO study director to initiate the internal reviewing process of draft...