- 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)
- …activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders and ... to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is...external CRO partners such as Global Regulatory Compliance, Global Labeling,… 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
- Merck (Boston, MA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... release from our company to external agencies and investigators. + Represents Global Regulatory Affairs (GR) within internal committees to provide … 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
- 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 (Prostate Cancer)** 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
- 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
- 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 (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- Merck (Boston, MA)
- …up with the latest regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and ensure submission readiness in all ... **Job Description** The Executive Director , Device Quality & Regulatory will...emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **Objectives/Purpose** The Associate Director , Global Medical Communications, Immunology is a key strategic ... partner of the Global Medical Affairs team, responsible for dynamically...assets. In strategic partnership with cross-functional stakeholders, the Associate Director , Global Medical Communications, Immunology will: +… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more