- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will ... define, develop and lead global strategies to maximize global ...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Boston, MA)
- …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)
- …understands probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level ... 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 Affairs ** . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs + Include the qualifications preferred… more
- Sumitomo Pharma (Boston, MA)
- … Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- AbbVie (Waltham, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory ... approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …might look like:** + Responsible for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC) for investigational and ... this key leadership role, you will build and oversee Global Regulatory Science and Regulatory ... leadership and oversight to the development of innovative regulatory affairs and CMC regulatory … more
- ThermoFisher Scientific (Waltham, MA)
- …opportunities to make significant contributions to the world. **Discover Impactful Work:** The Director of Regulatory Affairs (RA) is responsible for owning ... Director is able to combine knowledge of scientific, regulatory and business issues to enable products that are...global Q&RA system efficiencies to meet customer and global regulatory standards + Reviews and approves… more
- Sumitomo Pharma (Boston, MA)
- …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...member of the Medical Affairs team reporting to the Executive Director ,… more
- AbbVie (Cambridge, MA)
- …understanding of relevant therapeutic area required. + 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred. + ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more
- Sumitomo Pharma (Boston, MA)
- …Director , Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains… more
- Sumitomo Pharma (Boston, MA)
- …, Medical Strategy (Women's Health) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties… more
- AbbVie (Cambridge, MA)
- …statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + Experience in Neuroscience/Psychiatry preferred. + May assist as consultant ... be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational input into core… more
- Sumitomo Pharma (Boston, MA)
- …. **Job Overview** Director , Field Medical and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...key insights obtained from the RDs to the Medical Affairs and other internal stakeholders in a timely manner.… more
- ThermoFisher Scientific (Waltham, MA)
- …and pharmaceutical services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational ... talent development within the team. Reporting to the Senior Director of Regulatory Affairs , the...compliance within LPE. Responsible for leading and developing the global RA team supporting LPE. Responsible for reviewing and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Global Medical Affairs Lead, Plasma-Derived Therapies Innovations where you will ... and Regulatory to ensure proper and ethical interactions between PDT Global Medical Affairs personnel and external stakeholders + Planning, designing and… more
- Bristol Myers Squibb (Boston, MA)
- …Collaboration : Serve as the primary point of contact for internal (Medical Affairs , Development, Commercial, Regulatory Affairs , Legal, and Compliance) and ... record of successfully developing, centralizing and managing MAPs across a portfolio. + Regulatory / Compliance Knowledge: In-depth knowledge of global and local… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation where you will ... define, develop and lead global strategies to maximize global ...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... + Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of … more