- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead ... order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs, Neuroscience...technical success for the mitigation strategies proposed. + The Sr Director / Director will be accountable… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory success towards ... and influencing the field as applicable. + Provides leadership and development for other global regulatory leads responsible for the design and execution of … more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… 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, ... NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...potential risks to inform decision-making across the organization. + ** Global Regulatory Submissions:** + Oversee the planning,… more
- Takeda Pharmaceuticals (Boston, MA)
- …technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- Sumitomo Pharma (Boston, MA)
- … Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...as the Regulatory reviewer for assigned products. This position is responsible… more
- Hologic (Boston, MA)
- Sr Director , Global Supply Chain, IT Solutions Boston, MA, United States ** Sr . Director , Global Supply Chain IT Solutions** **Location:** ... to 25% **About the Role** Hologic is seeking a Sr . Director , Global Supply Chain...supply chain system implementations, optimize operations, and partner with senior leadership to deliver innovative technology at scale. Manage… more