- United Therapeutics (Research Triangle Park, NC)
- …the back of your hand - you might be exactly who we're looking for. The Regulatory Affairs Manager will manage and lead the preparation, compilation, and ... for assigned projects. This role will collaborate with the manager , project teams, and functional area representatives to devise...discipline + 8+ years of direct experience with a regulatory affairs CMC role with… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies to patients worldwide. Join Takeda as an Senior Manager , Global Regulatory Affairs , CMC Small Molecules where you will oversee the ... recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge,...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- ThermoFisher Scientific (Grand Island, NY)
- …Chemistry, or related field; advanced degree preferred + 7 years of experience in CMC regulatory affairs within the pharmaceutical industry + 1+ year ... Practices (GMP) Safety Standards, Office **Job Description** The Sr. Manager , Regulatory Affairs - Drug...regulatory standards + Provide strategic mentorship on applicable CMC regulatory submissions and support for customers… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes.** **Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC .** **As assigned, supports development of CSL policy positions… more
- CSL Behring (King Of Prussia, PA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges,… more
- CSL Behring (Waltham, MA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Mitsubishi Tanabe Pharma Group,… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …comprises four core domains: Global Health Integrated Development Expertise (GHIDE), Regulatory Affairs , Decision, Analyze, Communicate (DAC), and Chemistry, ... Manufacturing & Controls ( CMC ). IDev plays a critical role in advancing the...our product development investments are guided by robust data, regulatory insight, and operational excellence. Please note that the… more
- AbbVie (Irvine, CA)
- …brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs , etc., and ... Asset Plan and PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. + Ensures that the AST… more
- ThermoFisher Scientific (Greenville, NC)
- …deliverables + Advanced, broad understanding of global/regional/national country requirements/ regulatory affairs procedures for clinical trial authorization, ... in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing...global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC… more
- AbbVie (North Chicago, IL)
- …to use their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business objectives into actionable ... with experience in drug substance and/or drug product transfers. The program manager is to provide strategic oversight for one or more industrialization programs,… more