- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC , with significant experience in small molecules is ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing… more
- Takeda Pharmaceuticals (Boston, MA)
- …as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned ... strategy. + Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- Sanofi Group (Waltham, MA)
- …automation + Experience with emerging digital technologies in pharmaceutical development and/or regulatory affairs + Skilled in AI applications and prompt ... critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable...leading the preparation of CMC dossiers for regulatory submissions to enable advancement of company's product development… 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 ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- Merck (Boston, MA)
- …on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs , clinical operations, and CMC teams. + ... implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert...robust study design and high-quality PET data collection. + ** Regulatory support** : Familiarity with regulatory and… more
- Sumitomo Pharma (Boston, MA)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the...Global Regulatory Affairs (GRA) team based in the US. He/She will...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Takeda Pharmaceuticals (Boston, MA)
- …concepts into business terms. + Experience with regulatory domains such as Labeling, CMC , and broader Regulatory Affairs processes. + Exposure to public ... regulatory requirements (eg, IDMP, SPOR, XEVMPD, eCTD, ePI, PQ/ CMC , CTIS, ESMP) and assess their impact on RIM...or a related field** required. + Master's degree in ** Regulatory Affairs , Data Management, or related discipline**… more
- Parexel (Boston, MA)
- …and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge ... to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as...in line with local legislation (renewals, PSURs, label updates, CMC changes). * Execute timely data entry and validation… more
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …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