About the Role: Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned development projects leading to s...
Endocrinology programs, including rare and obesity indications Integrates scientific, clinical, safety, and commercial... with Clinical Development, Safety, Commercial, CMC, Quality, and Legal to ensure aligned and value-generating regulatory strategies...
Officer, helps build, develop, lead and drive the Company’s preclinical through clinical pipeline. This leader is responsible... of specific responsibility and attention will include the following: · Provide leadership and clinical perspective to the...
Position Summary (Hybrid;2-3 days in office) The Clinical Trials Manager is responsible for the delivery of a key... phase 3 clinical trial. This individual will contribute to the success of the team and organization by delivering high...
Associate Director or Director, Regulatory Affairs (Hybrid 3 days in office) How you’ll make an impact: The Associate Director or Director of Regulatory Affairs will be a key member of the STAT6 Regulatory team working in partnership wi...
manufacture of Drug Product (DP) in support of ongoing clinical programs and commercial supply · Development of robust, scalable... manufacturing processes for drug substance and drug product formulations to support clinical studies. · Responsible for technology...