- AstraZeneca GmbH (Boston, MA)
- …will do:Position SummaryThe Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA- CMC ) will be responsible for ... leading and providing global CMC regulatory support for the clinical and...teleconferences with regulatory authorities.Partner with representatives of Regulatory Affairs including in-country regulatory … more
- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director/Senior Director, the ... responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide ...development or commercial products.In depth knowledge and application of global CMC guidelines regarding IND/BLAs or post… more
- Eisai, Inc (Exton, PA)
- … strategies throughout the lifecycle of pharmaceuticals. Coordinates the preparation of CMC regulatory submissions that meet global regulatory ... ways to improve efficiency. Essential Functions 1. Development Projects Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Ironwood Pharmaceuticals (Boston, MA)
- …burden of GI diseases and address significant unmet needs. Position Summary: Lead the Regulatory Affairs CMC function supporting process development and the ... on requirements and advance filings. Major Responsibilities: Lead the Regulatory Affairs - CMC function and set...teams and ensure timely development and execution of robust global regulatory strategies, regulatory risk… more
- PSG Global Solutions (Cambridge, MA)
- DescriptionWe're looking for an Associate Director Regulatory Affairs CMC , working in the Pharmaceuticals and Medical Products industry in Cambridge, ... Massachusetts, United States.Responsibilities:Leads development and execution of robust global regulatory CMC strategy for assigned program(s) with balanced… more
- Avidity Biosciences, Inc. (San Diego, CA)
- …and engage with us on LinkedIn and Twitter.The OpportunityReporting to the Director, CMC Regulatory Affairs , the successful candidate will work independently ... matter experts and manage and execute CMC regulatory submissions to facilitate the global development...Degree required; Advanced Degree preferred.5+ years of experience in Regulatory Affairs with a CMC … more
- Kyverna Therapeutics, Inc. (Emeryville, CA)
- …autoimmune diseases are treated.Kyverna is seeking an experienced and passionate Associate Director, CMC Regulatory Affairs with a strong background in cell ... are looking for candidates with 3-5+ years of direct CMC Regulatory Affairs experience who...innovative CAR T cell therapies.Responsibilities:Support development and execution of global Regulatory CMC strategies for… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …to us as an organization.The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all ... assigned projects effectively.Responsibilities:Oversee and direct all CMC regulatory strategies in compliance with global ...CMC regulatory strategies in compliance with global regulatory requirements for the development of… more
- Adverum Biotechnologies (Redwood City, CA)
- … compliance. The Director/Sr will be responsible for developing, executing, and advising on global Regulatory CMC strategies through all phases of Adverum's ... The Director/Sr Regulatory Affairs will lead the overall CMC ...as an internal consultant on relevant global CMC regulations and guidelines, current regulatory environment,… more
- Vir Biotechnology, Inc. (San Francisco, CA)
- …degree or certificate. 12+ years experience in pharmaceutical product development including strong global Regulatory CMC leadership. Regulatory CMC ... This position will work closely with the Technical Operations ( CMC ) functional groups and Regulatory Affairs...regulatory requirements and enable Vir business objectives. Provide CMC regulatory expertise to enable global… more
- Neogene Therapeutics (Santa Monica, CA)
- …and based in Santa Monica, CA and reports to the Executive Director, CMC Regulatory Affairs .ResponsibilitiesInterpret global regulations and guidance ... to achieve the next wave of breakthroughs.Position SummaryThe AD CMC Regulatory Affairs supports the...years with PhD.Prior experience in cell/gene therapy.In-depth knowledge of global CMC regulations and understanding of evolving… more
- Gilead Sciences, Inc. (Foster City, CA)
- Associate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory AffairsJob DescriptionAt Gilead, we're creating a healthier world ... analytical flexibility the incumbent will support "right first time" global approvals for CMC control strategies and...for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- ACIP (MA)
- SENIOR VICE PRESIDENT OR VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS Nanobiotix - a brief historyEst. 2003, Nanobiotix is a clinical-stage biotechnology ... regarding regulations, directives, and guidance Hire, train, and manage regulatory affairs department (currently six staff) CANDIDATE SPECIFICATIONEssential:… more
- Tango Therapeutics (Boston, MA)
- …Summary Tango has an exciting new opportunity to join the team as a Vice President, Regulatory Affairs . Reporting to the President, R&D, the VP, Regulatory ... Affairs will lead Regulatory Affairs for Tango Therapeutics, and will drive the development...Tango Therapeutics, and will drive the development of innovative global regulatory strategies. Responsible for the preparation… more
- Orca Bio (Menlo Park, CA)
- …immune systems with healthy ones, but also restore their lives.The (Sr.) VP/Head of Regulatory Affairs will lead the company's regulatory strategy and ... the overall strategic direction and execution of US and global regulatory plans for Orca Bio's product...ensure alignment and timely feedback.Build, mentor, and lead the Regulatory Affairs team, ensuring team members are… more
- CLevelCrossing (San Francisco, CA)
- …the Regulatory Team that may include external consultants or other Clinical or CMC Regulatory Affairs personnel, Regulatory Medical Writing, Quality ... initially to the Chief Development Officer, the VP of Regulatory Affairs will support the company mission...the company mission by overseeing the following functions: Clinical Regulatory CMC Regulatory Medical Writing… more
- Ascendis Pharma A/S (Palo Alto, CA)
- …Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC ... in Palo Alto, CA.Key ResponsibilitiesResponsible for strategic and operational regulatory input for cross functional ( CMC , non-clinical...of current global and regional trends in regulatory affairs and ability to assess the… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- The position is responsible for supporting and leading activities within Regulatory Affairs department, to support clinical development of oncology products at ... and maintain strong relationships with the FDA and other global regulatory agencies. Grow corporate, project and...related field, advanced degree preferred.At least 8+ years of regulatory affairs experience for the associate director… more
