- Merck & Co. (Boston, MA)
- …and executing integrated development plans that align clinical, medical affairs , commercial, manufacturing, regulatory , analytical, and epidemiological ... DescriptionOur Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and… more
- Commonwealth Care Alliance (Boston, MA)
- …collaboration with Clinical Vice Presidents/Medical Directors and the Vice President, Regulatory Affairs and Compliance - Participates in senior-level strategic ... 021350 Clin Alli-Care Delivery Administration Position Summary: The Director , Behavioral Health Care Delivery is responsible for the strategy and leadership of CCA's… more
- CSL Behring (Waltham, MA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, ... the Executive Director Head Regulatory . **Position Description** **Summary** - Regulatory leaders who support development of a global , integrated … more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion ... GRA A&P SME for assigned products and projects. + Regulatory advisor as the "R" in the core Medical,...and implementation + Product or project business lead for global CMRP at Takeda + CMRP Meeting Chair- pausing… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Job Title:** Associate Director - Analytics, Global Regulatory Affairs **Role Purpose:** Strategic and operational ... oversight of custom analytics deliveries from Global Regulatory Affairs involving Business Intelligence solutions and related semantic layer dependencies.… 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
- Takeda Pharmaceuticals (Boston, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals… more
- Rhythm Pharmaceuticals (Boston, MA)
- …commercialization and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities and Duties ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
- Sumitomo Pharma (Boston, MA)
- …Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... function as a regional regulatory leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… 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
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting… more
- Takeda Pharmaceuticals (Boston, MA)
- …grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications ... in coordination with relevant cross-functional teams (including members of medical affairs , clinical development, and outcomes research; global , regional, or… more
- Danaher Corporation (Boston, MA)
- …sector. This position reports to the Director , Regulatory Affairs and is part of the Global Regulatory Affairs and will be fully remote. In ... pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in… more
- Wolters Kluwer (Waltham, MA)
- About Wolters Kluwer Wolters Kluwer is a global leader in professional information, software solutions, and services for clinicians, nurses, accountants, lawyers, ... and tax, finance, audit, risk, compliance, and regulatory sectors. We help professionals deliver deep impact when...professionals deliver deep impact when it matters most. The Global Communications team at Wolters Kluwer, which is responsible… more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as Associate Director , Global Regulatory Lead Oncology where you will be part ... of the global regulatory team. As Associate Director...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Boston, MA)
- … system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and ... accurate and timely reporting for both common and ad hoc regulatory affairs questions. **ACCOUNTABILITIES:** ** Global GRIDS Strategy Development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Director , Global Regulatory Lead Oncology where you will be part ... of the global regulatory team. As ...of the global regulatory team. As Director , ...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… 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 ... + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned… more
- Takeda Pharmaceuticals (Boston, MA)
- …the role:** The **Head of Ethics & Compliance (E&C) for PDT R&D and Medical Affairs ** at the senior director level is a senior leader responsible for managing ... the E&C program across PDT R&D and Medical Affairs , and driving continuous improvement aligned with the strategic...audits; and delivering E&C training. The role also supports global initiatives, digital ethics, and data privacy efforts, while… more
- Orchard Therapeutics (Boston, MA)
- …or PhD in a scientific discipline preferred. . At least 15 years experience in Regulatory Affairs in the Biotech environment, spanning US regulatory science ... Location: Boston, MA Main responsibilities The Executive Director (ED) Regulatory Science will actively... Regulatory CMC team and the VP of Regulatory Science, to ensure a consistent global … more
