- Merck & Co. (North Wales, PA)
- …The Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide CMC Regulatory ... application of global CMC guidelines regarding IND/BLAs or post approval changes.The CMC Project Lead is accountable for the delivery of all regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Gather business requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs teams and cross-functional project team ... Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … changes for portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Head of CMC Regulatory Affairs - Small Molecules** **KEY RESPONSIBILITIES** The ... Head of CMC Regulatory Affairs - Small...is deeply integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams and overall goals. The role will report… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program ... regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC ...as required. Participate in and/or lead agency meetings on CMC topics. + Ensure project team colleagues,… more
- Taiho Oncology (Pleasanton, CA)
- Director, Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March 26, 2024 Looking for a chance to make a meaningful difference in the oncology ... mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive...consultation with Global Executive Director or designee. + Prepare project and/or status reports as assigned. + Ensures that… more
- Lilly (Indianapolis, IN)
- …for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... group to support global submissions and registrations. As the project leader, you will be expected to collaborate with...knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for… more
- BeiGene (Emeryville, CA)
- …taken when recalls or product complaints arise during product lifecycle for the assigned project . . Provide CMC regulatory review for clinical protocols and ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on... regulatory strategies as well as authoring CTD CMC sections for the assigned project to… more
- Lilly (Indianapolis, IN)
- …better for people around the world. Organization Overview: The Global CMC Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery ... specialists, and project management for marketed product support. Responsibilities:: ** Regulatory & Drug Development Expertise** + Lead CMC submission… more
- Merck (North Wales, PA)
- …Principal Scientist / Director responsibilities include but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory ... guidelines regarding IND/BLAs or post approval changes. + The CMC Project Lead is accountable for the...Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to… more
- Amicus Therapeutics (Marlow, OK)
- …candidate responsible for leading Chemistry, Manufacturing and Controls ( CMC ) regulatory activities for commercial phase large molecule project . The ... matter experts in Tech Ops, Science, Quality and Global Regulatory Affairs to ensure timely delivery of...and ensuring seamless communication. The candidate will ensure all CMC regulatory submissions (such as pre-submission consultation… more
- Takeda Pharmaceuticals (Boston, MA)
- …Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs , Pharmaceuticals. **How you will contribute:** ... team in the development and implementation of global CMC regulatory strategies during development commercialization and...across a very complex matrix environment in GRA with CMC RA project leads and other GRA… more
- CSL Behring (King Of Prussia, PA)
- …business objectives and current health authority expectations. o Provides communications between Global Regulatory Affairs CMC and partners within GRA and ... you be our next CSL Plasma Lead for Global Regulatory Affairs , Plasma? This position is located...the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project… more
- Organon & Co. (Jersey City, NJ)
- …to: **Responsibilities** + Provide input to global product and project regulatory strategiesby performing assessments of CMC changes, identifying global ... for the preparation and review of information required for development of regulatory CMC dossiers for products including original registrations, life-cycle… more
- ThermoFisher Scientific (Wilmington, NC)
- …Talent Acquisition, Project Delivery and Bids/Contracts to support the Regulatory Affairs proposal process including client presentations. + Provides ... the job, including several years of specific experience in a regulatory affairs function and speciality area (preclinical, clinical, CMC , publishing, etc) +… more
- Ascendis Pharma (Palo Alto, CA)
- …strategic and operational regulatory input and support for cross functional ( CMC , non-clinical and clinical) collaboration with other project team members. + ... to all aspects of the business, from drug development to marketing. The Manager, Regulatory Affairs will be responsible for supporting and developing global … more
- University of Colorado (Aurora, CO)
- Regulatory Affairs Program Director - 32624 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Gates Institute** ... **Job Title: Regulatory Affairs Program Director** **Position #00819327 -...project teams, and continuously evaluating the feasibility of regulatory strategic plans. + Leading cross-functional collaboration to ensure… more
- Ascendis Pharma (Palo Alto, CA)
- …clinical, non-clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans for project teams with ... The Director, Regulatory Affairs will be responsible for...international participants. May mentor and potentially supervise other regulatory professionals working on the project team… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director, Regulatory Affairs - West Chester, PA Date: Mar 26, 2024 Location: West Chester, United States, 1938 Company: Teva Pharmaceuticals Job Id: ... **How you'll spend your day** As the Associate Director, Regulatory Affairs you will be responsible for...Project Team (CPT), Clinical Development Team (CDT), and CMC Team to ensure successful planning and execution of… more
- Lauridsen Group Inc. (Ankeny, IA)
- The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international ... implement regulatory strategies. The Senior Manager of Regulatory Affairs is responsible for leading and...ensure alignment with overarching PHB business strategies. + Provide regulatory leadership with expertise in CMC and… more
