- Sanofi Group (Cambridge, MA)
- …limits of what you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the ... **Job title: Global Regulatory Lead ** +...**Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ...in R&D, including at least 10 years of relevant Regulatory Affairs experience (regionally and/or global… more
- Takeda Pharmaceuticals (Boston, MA)
- …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)
- …therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in ... data and information. + Actively participates on the PDT Global Regulatory Affairs Leadership Team,...to lead cross-functional teams, develop and implement global regulatory strategies, facilitate approvals, resolve complex… more
- Philips (Cambridge, MA)
- The Director of Regulatory Affairs & Quality will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in the ... strategies and quality team/QMS responsibilities. **Your role:** + Leading Regulatory Affairs strategy end-to-end execution (product inception through to… more
- Philips (Cambridge, MA)
- …plan, and outline proposal for balancing the project risk to project teams and Regulatory Affairs Management. + Lead communication and negotiation efforts ... The Principal Regulatory Affairs Specialist will play a...+ You have a strong understanding of all relevant global regulatory requirements, flexibility and adaptability to… more
- Bausch + Lomb (Boston, MA)
- …the future. **Objectives** A member of the global technical CMC team for global regulatory CMC strategy for submissions and content of CMC dossiers for ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...interdisciplinary project teams and to appropriate management level in Regulatory Affairs , R&D, TechOps and Supply Chain… more
- Takeda Pharmaceuticals (Boston, MA)
- …in medical affairs and Neuroscience.** **Experience successfully leading global cross-functional teams.** **Demonstrated ability to create, lead , and ... **Leads and expands Neuroscience Therapeutic Area (TA) including hiring of Global Medical Affairs (GMA) professionals covering different therapeutic indications… 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
- J&J Family of Companies (Raynham, MA)
- …+ Work with cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics & Market Access (HEMA) ... PRA) documents. + Lead , mentor and coach a team of Medical Affairs professionals. **Qualifications** **Requirements** + Minimum of an MD Degree or equivalent. +… more
- AbbVie (Cambridge, MA)
- …priority trials. Responsibilities + Contributes to the development of brand strategies. + Lead and support Medical Affairs initiatives (strategy and tactics) for ... EE Engagement Plan generation in line with TA plan. Lead the individual ( Global ) Conference planning and...area required. + 7-10 years of experience in Medical Affairs with Global Medical Affairs … more
- AbbVie (Cambridge, MA)
- …Key responsibilities include: + Contributes to the development of brand strategies. + Lead and support Medical Affairs initiatives (strategy and tactics) for ... EE Engagement Plan generation in line with TA plan. Lead the individual ( Global ) Conference planning and...regulatory , etc.) as they relate to on-going medical affairs projects. + May assist as consultant and liaison… more
- AbbVie (Cambridge, MA)
- …demonstrating strong leadership competencies and proven team-building skills with ability to lead in a global matrixed environment. Substantial understanding of ... medical input into core brand/product strategies. Works with TA Lead to ensure external communication strategies and tactics align...regulatory , etc.) as they relate to on-going medical affairs projects. + Ability to work effectively in a… 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 ... medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions (HCP's,… more
- AbbVie (Cambridge, MA)
- …demonstrating strong leadership competencies and proven team-building skills with ability to lead in a global matrixed environment. Substantial understanding of ... + Ability to interact externally and internally to support global business strategy. Ability to work effectively with different...regulatory , etc.) as they relate to on-going medical affairs projects. + Ability to work effectively in a… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate 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)
- … Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... **How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-...changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues… more
- Takeda Pharmaceuticals (Boston, MA)
- … Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to ... sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team,...lead complex outsourcing projects. + Deep understanding of regulatory information management + Savvy and effective negotiation skills… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …(Line) Expertise** + Comprehensive understanding of the pharmaceutical industry and medical affairs . + Global regulatory expertise with demonstrated strong ... communication plans through close collaboration with cross-functional teams (including Medical Affairs , Clinical Development, Regulatory Affairs , Commercial,… more
- Takeda Pharmaceuticals (Boston, MA)
- …and others, as appropriate). + Lead development and execution of the global medical affairs (GMA) strategic and tactical plans, in collaboration with GMUH. ... with both internal and external audiences. + Establish the Global Medical Lead as the Takeda trusted...regulatory authorities. + Develop, support, and prioritize a global KOL engagement strategy for the respective diseases. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more