- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a ... Senior Manager of Statistics, you will provide statistical leadership in...assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …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 ...to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and… more
- AbbVie (North Chicago, IL)
- …. Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and external partners ... Participates in initiatives internal to RA CMC . Represents CMC regulatory affairs on project initiatives with other functional areas to drive… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs ( RA ) Specialist within the BD Interventional Surgical Devices Business unit will work on ... Under the mentorship of the Sr. RA Manager of Regulatory Affairs , they...medical devices in the US The Senior RA Specialist will also support related regulatory … more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC - RA , labeling, medical writing, ... years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, quality… more
- Boehringer Ingelheim (Duluth, GA)
- …will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with RA project team members, helps drives cross ... Operations Excellence Partner is to partner with the USA Regulatory Affairs team in executing key strategic...strategic and operational initiatives to achieve USA priorities for RA and USA CMC objectives. This role… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the ... by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug… more
- Pfizer (Groton, CT)
- …scope, the position provides growth opportunities in Operations, Strategy, and Digital. ** Senior Manager :** + Formal leadership role of data coordinators ... ** Regulatory , Data Steward & Team Lead (Sr. Manager )** Vault RIM process and system is highly dependent...years of experience or Master's degree in Life Sciences, Regulatory Affairs , Data Management, or related field.… more
- ThermoFisher Scientific (Greenville, NC)
- …deliverables + Advanced, broad understanding of global/regional/national country requirements/ regulatory affairs procedures for clinical trial authorization, ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
- ThermoFisher Scientific (Greenville, NC)
- …deliverables + Advanced, broad understanding of global/regional/national country requirements/ regulatory affairs procedures for clinical trial authorization, ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more