- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages the scientific and ... to lead preparation, review, and finalization of CMC documents for global regulatory submissions, including Clinical Trial Applications, Market Authorization… more
- Lilly (Indianapolis, IN)
- …solutions to support communities through philanthropy and volunteerism. **Organization Overview:** Global Regulatory Policy & Strategy strives to enable Lilly ... efficiency in drug development. The purpose of the Associate Vice President - Global Regulatory Affairs, Global Regulatory Policy & Strategy (Genetic… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides… more
- Fresenius Medical Center (Waltham, MA)
- …+ ** Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical portfolio, including IND/CTAs, ... strategies, and potential risks to inform decision-making across the organization. + ** Global Regulatory Submissions:** + Oversee the planning, preparation, and… more
- BeOne Medicines (Emeryville, CA)
- **General Description** **_:_** + The Director, Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... Franchise (Solid Tumors), with a focus on gastrointestinal (GI) indications and a global regulatory remit. **Responsibilities:** + Provides high level global … more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is ... to develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area. The GRL is the accountable decision maker for… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global … more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director) **Location** : Cambridge, MA or Morristown, ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination Products… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What you will ... Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Lead **Location** : Morristown, NJ, Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the… more
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