Career Category Regulatory Job Description The Regulatory Affairs CMC Site Team is responsible for input to the... development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the...
us at | Who You Are This experienced Regulatory Affairs team member will provide CMC regulatory expertise and support... stakeholders. This individual will represent CMC Regulatory Affairs on CMC and Regulatory sub-teams with respect to RA CMC...
advances to patients who live with genetic diseases. As a Senior Manager in the Regulatory CMC department this individual... is a plus. EXPERIENCE At least 7 years of experience in Regulatory Affairs CMC or a related discipline in the pharmaceutical...
) About the Role: Join our dynamic team at Neurocrine as a Senior Regulatory CMC Manager where you'll play a crucial role... in shaping the regulatory CMC strategy and driving the successful preparation and approval of IND/CTA/MAA/NDA/BLA submissions...
, Regulatory Affairs, to join our pharmaceutical team. This role will involve leading and managing regulatory activities to support... Experience: Minimum: 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry...
SUMMARY OF POSITION The Sr. Manager, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines... experience, at 8+ years in Regulatory Affairs with emphasis on CMC. Must have managerial experience. Exhibits excellent...
of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions... manner. Sr Reg Affairs Specialist I Primary responsibilities for role: Act as Regulatory Affairs representative...
of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions... manner. Sr Reg Affairs Specialist I Primary responsibilities for role: Act as Regulatory Affairs representative...
and/or biologics CMC programs. The Sr. Project Manager will partner with PDM Product Strategy Team Leads to manage a cross-functional.... Job Description Title: Sr. Manager, Project Management Location: Foster City Specific Responsibilities: The Senior Project Manager...
collaboration with stakeholders, such as Clinical Operations, Regulatory Affairs, Quality, Manufacturing, and Pro No matter... and company culture, visit us at | Who You Are The Director/Sr. Director, Clinical Supply Chain Management will be responsible...
and contractors, ensuring compliance with terms, quality, and deadlines. Compliance and Regulatory Affairs: Plan and execute... solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing...
or global study lead (e.g., Medical Monitor, Regulatory Affairs, Safety, CMC, Supply Chain, CQA, CRO, vendors and Investigators... Trial Manager (Sr. CTM) is responsible for management of clinical trials from study start-up activities through the clinical...