- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …Preferred **Knowledge and skills** + Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required + Solid ... labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global strategy and key… more
- Bristol Myers Squibb (Madison, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director Commercial Regulatory Affairs** **Description** : The ... role of Associate Director of US Commercial Regulatory Affairs requires...and subpart E and H submissions + Ensure full regulatory compliance of all promotions with approved labeling… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, 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 US. He/She...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead ( Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... on mission, prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling strategy + Ensures… more
- GRAIL (Trenton, NJ)
- …For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal ... including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements,… more
- Ascendis Pharma (Princeton, NJ)
- …As a member of the Endocrine Medical Sciences team for the US business, the Associate Medical Director supports the US Medical Director for deliverables and ... boundaries of company compliance SOP's and US regulations). The Associate Medical Director is expected to develop...for assigned product(s), and collaborate with Commercial, Legal, and Regulatory for development and review of Labeling ,… more
- Taiho Oncology (Princeton, NJ)
- …Value Proposition: Embark on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of pharmacovigilance ... on your experience in our rapidly evolving organization. Position Summary: The Associate Director , PV Sciences role will lead medical surveillance activities… more