Associate Director Regulatory Cmc Jobs

... for the development of the CMC regulatory strategy for submissions. These submissions ... IND/CTA, NDA, CTD and MAA regulatory filings. Collaborate with other relevant ... functions to prepare and..

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas ..

... results. Functional Area Description The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of ... of the organization develop global regulatory CMC strategies and partners..

... on internal/external system audits and regulatory agency inspections Responsible for business ... documentation system in compliance with regulatory requirements, company requirements and procedures; ... research, analytical, quality, engineering, manufacturing,..

... that achieve commercial goals and regulatory requirements for multiple functions. Generates ... evaluates Clinical Pharmacology, PK/PD or regulatory advances, strengths, weaknesses, opportunities and ... context of research question). Author..

... Therapeutic Area Head Support the Regulatory Affairs Therapeutic Area Head for ... leading and developing the global regulatory strategies, overseeing health authority interactions ... hiring, retention, and development of..

... Product Quality Lead (Principal PQL), Associate Director of Global Product Quality. The ... Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy ... Therapy Development Organizations to..

... Purpose and Scope: The Senior Associate, CMC Regulatory Affairs (RA) is responsible to ... (RA) is responsible to support CMC regulatory activities for our company's products ... content input..

... who will be accountable for CMC product strategy to enable advancement ... include leading or managing the CMC PST, representing CMC at Vir Program Team meetings, ... alliance partnerships..

... control to ensure we meet regulatory standards, and procure the needed ... point of contact on the CMC (Chemistry, Manufacturing and Controls) team ... a core member of the..

... results. Functional Area Description The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of ... of the organization develop global regulatory CMC strategies and partners..

Sr. Director, Regulatory Affairs CMC n n nThis position is ... position is responsible for the CMC strategic regulatory direction, interactions with U.S. and ... interactions with U.S. and international..

... global leadership role in the Regulatory Affairs department for the Chemistry, ... the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for ... and submissions...

... mastery of the fundamentals of regulatory affairs, the Associate Director will have the key role ... goals. Reporting to the Executive Director, Head of Regulatory Affairs, The Associate Director..

... near the Dublin-Pleasanton BART station.rnrnThe Associate Director, Analytical Development will be responsible ... analytical development projects within the CMC team, including collaborating with CMOs ... are developed and qualified..

Senior Director, Regulatory Affairs n nThis position is ... overseeing, supervising, and managing the Regulatory Affairs (RA) function. This includes ... Affairs (RA) function. This includes Regulatory CMC, Regulatory Program..

... diseases. SUMMARY DESCRIPTIONAs a Senior/Executive Director in Regulatory Affairs, CMC, focusing on diagnostics and medical ... responsible for establishing the overall regulatory strategy for contemporaneous development of ... will..

... make a difference. Position: Executive Director, Regulatory Affairs Team Leader Supervisor: Vice ... Team Leader Supervisor: Vice President, Regulatory Affairs Department: Global Regulatory Affairs Prerequisites Bachelors in scientific .....

... control to ensure we meet regulatory standards, and procure the needed ... point of contact on the CMC (Chemistry, Manufacturing and Controls) team ... a core member of the..

... will Achieve More with Intellia:The Associate Director, Clinical Operations is an integral ... Data Management and Biostatistics, Medical, Regulatory Affairs, Clinical Pharmacology, Clinical Supply ... Clinical Pharmacology, Clinical Supply..

... transformative business results. Summary The CMC Regulatory Associate Director is responsible for content development, ... of the Quality Module for regulatory submissions to support biotechnology products ... submissions. In..

... transformative business results. Summary The CMC Regulatory Associate Director is responsible for content development, ... of the Quality Module for regulatory submissions to support biotechnology products ... submissions. In..

... manage, and execute a complete CMC strategy for BMS biologics commercial ... develop and deliver on the CMC strategy while ensuring that the ... customer service targets, successfully achieving..