We are seeking an experienced and strategic Senior Director, Regulatory Affairs - CMC to lead global CMC regulatory... of pharmaceutical or biotechnology industry experience. Minimum 8-10 years of direct Regulatory Affairs CMC experience. Demonstrated...
of Regulatory Affairs CMC, the Director, Global Regulatory Affairs - CMC is responsible for owning and leading the global CMC..., and fully integrated into development and commercial plans. The Director serves as the single-point CMC regulatory lead...
, reporting to the Senior Director, Regulatory Affairs CMC, you will be responsible for developing and executing the CMC... and other presentations . About the Role Associate Director, Regulatory Affairs CMC As the Associate Director, Regulatory Affairs CMC...
Senior Director, Regulatory Affairs - Boston, MA We're partnering with a leading Boston-based oncology biotech... to find a Senior Director of Regulatory Affairs to lead global regulatory strategy across their clinical development pipeline...
Manager, Regulatory Affairs Operations, to join our team. Reporting to the Director, Regulatory Affairs, this individual...-functionally with Regulatory Affairs, Clinical, Quality, and CMC to ensure submission readiness and compliance. Skills...
Position Overview The Senior Director, Analytical Sciences will provide late-stage analytical leadership for complex..., regulatory affairs, and manufacturing, to ensure seamless integration and success. Qualifications Ph.D. in biochemical...
and other presentations . About the Role Senior Director, Program Management - Oncology (NDA Lead) As the Senior Director of Program... across Clinical, Regulatory, CMC Quality, and Commercial functions to meet program goals, regulatory timelines, and quality standards...
with Clinical Operations, CMC, Quality, Regulatory, Finance, and external vendors. Reporting to the Senior Director, Clinical Supply...: Collaborate with Quality, Clinical, CMC and external CDMOs to develop and approve clinical labels. Manage CDMO packaging/labeling...