- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing ... Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** : Reporting to the Vice President, Global Medical Affairs , the Executive Director, CNS Strategy, Global Medical Affairs is a ... but are not limited to the following: + Represents Global Medical Affairs on extended...and self-improvement + Demonstrates experience interacting with and supporting senior leadership + Ability to champion new ideas or… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of ...or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Utlizes profound GRA CMC knowledge underpinned by a deep understanding of global drug development and regulatory essentials to address and overcome challenges that ... timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality...- technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a… more
- Danaher Corporation (Boston, MA)
- …pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in ... Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for… more
- Fresenius Medical Center (Waltham, MA)
- …NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership in medical /clinical development, commercial, and other functional ... for cross-functional teams, ensuring alignment on regulatory strategy and execution across global markets. + Work closely with commercial, clinical/ medical , and… more
- AbbVie (Waltham, MA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for… more
- Edwards Lifesciences (Boston, MA)
- Patients are at the heart of everything we do. As the Senior Director, THV Medical Affairs , you will drive strategy development, evidence generation ... health economics and outcomes research teams ensuring seamless integration of medical affairs initiatives into broader organizational efforts. + Building… more
- 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:** + Plan, ... Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by applying interpersonal...US based employees may be eligible to participate in medical , dental, vision insurance, a 401(k) plan and company… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... you thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of… more