- Repligen (Waltham, MA)
- OverviewMake a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs ... and every contribution drives progress. Join us!Our fast-growing and acquisitive global public company is seeking a strong, experienced, and technically sound… more
- BC Platforms (Somerville, MA)
- …hours) About the Role BC Platforms is looking for a driven and results-oriented Sales Director , Life Sciences to join our growing global team. This role is based ... across our portfolio of Life Science customers. As Sales Director , you will lead the sales of...have the unique ability to provide unmatched access to global , research-ready, regulatory -grade patient data. This is… more
- Takeda Pharmaceuticals (Boston, MA)
- …opportunities. + Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific ... Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory...oversees direct reports or other staff responsible. The Senior Director will lead all submission types. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead ... success for the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US...Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for ... reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types...Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies… more
- Candela Corporation (Marlborough, MA)
- ** Director , Global Regulatory Affairs** Requisition Number **2872** Location **US - Marlborough, MA** State/Territory **Massachusetts** **Company Overview:** ... distributors in over 60 other countries. **General Summary** The Director , Global RA will be fully accountable... submission/approval dates. + Developing and maintaining partnerships with global regulatory agencies and act as Candela's… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **OBJECTIVES/PURPOSE:** Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global ... system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and the… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **Job Title:** Associate Director - Analytics, Global Regulatory Affairs **Role Purpose:** Strategic ... the semantic layer and custom analytics capabilities in alignment with the Global Regulatory Analytics lead . + Working with primary Business Stakeholders to… more
- Takeda Pharmaceuticals (Boston, MA)
- …development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications Lead , Hematology** proactively defines ... empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to...life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead , develops and implements… more
- Takeda Pharmaceuticals (Boston, MA)
- …Autonomy + Responsibility in line with Associate Director level position; independently lead HE projects and support the Global Health Economics Center of ... appropriate comparator + Co- lead with Market Access the development of the global value proposition to ensure a compelling value story for payers + Identify and… more
- Sumitomo Pharma (Boston, MA)
- …project(s) in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead ... The Associate Director is part of the Global Regulatory Affairs (GRA) team based in...Lead , manage regional (United States, European and/or ROW) regulatory activities as part of a Global … more
- Sumitomo Pharma (Boston, MA)
- …experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based ... the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory... Lead , manage regional (United States and/or European) regulatory activities as part of a Global … more
- Rhythm Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs. Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of ... with external manufacturing sites and suppliers to align change control processes with global regulatory expectations. + Ensure site compliance with global … more
- Pfizer (Cambridge, MA)
- …clinical trials and the development strategy for early development assets and lead development programs with a focus on multiple myeloma cross-functionally within ... team for post-POC (typically phase 3) development **ROLE RESPONSIBILITIES** + Lead , develop and execute strategic development for early development assets.(myeloma… more
- Chemours (Boston, MA)
- …and more modern living depend on Chemours chemistry. Chemours is seeking a ** Director of Regulatory Advocacy** to join our growing Government Affairs team! ... including agency and legislative leaders, to advocate the company's position on pending regulatory proposals and existing regulations. + Lead both in the macro… more
- Orchard Therapeutics (Boston, MA)
- …expert, the ED Regulatory Science will closely collaborate with the assigned US Regulatory lead , their peers in Europe, the Regulatory CMC team and ... Location: Boston, MA Main responsibilities The Executive Director (ED) Regulatory Science will actively...of Regulatory Science, to ensure a consistent global approach is used for the development and execution… more
- Bristol Myers Squibb (Cambridge, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position ... Summary:** The selected candidate will have leadership responsibility for global regulatory strategy within a development team...strategy within a development team (DT). Serve as team lead or co- lead of marketing application submission… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Director , Franchise Lead CNS Early Assets. **Position Summary:** The Medical Director , Global Medical Affairs, CNS Early Assets will be responsible for ... Neurology portfolio). This role will report to the Sr. Director , Global Medical Affairs, Franchise Lead... global value and real-world evidence, US and global commercial teams, market access, and regulatory … more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Medical Director , Rare Hematology **Location:** Cambridge, MA **About the Job** The Global Medical Director for Rare Hematology ... of the products in Sanofi Rare Hematology portfolio. The global medical director is accountable for ...Regulatory functions. This position will report to the Global Head of Rare Hematology Medical Affairs. The position… more
