- 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
- 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 (Providence, RI)
- …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 (Providence, RI)
- …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
- Chemours (Providence, RI)
- …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
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …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
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- **Job Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for ... leading a global team focused on R&D Quality. This ...are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage with regulatory… more
- Hologic (Boston, MA)
- …**Travel:** Up to 25% **About the Role** Hologic is seeking a Sr. Director , Global Supply Chain IT Solutions to lead the development and execution of our ... Sr Director , Global Supply Chain, IT Solutions...receive the highest standard of service. **Key Responsibilities** + Lead IT strategy and roadmap for global … more
- Renaissance (Providence, RI)
- …is accountable for legal and regulatory compliance. **In this role as Global Director ** **Total Rewards, you will have the following key responsibilities:** ... our actions, and grow and evolve. **Job Description** The Global Director of Total Rewards is responsible...**Strategy & Design** + Develop and lead the global total rewards strategy, including… more
- Sanofi Group (Framingham, MA)
- …families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team ... **Job Title:** GRA Device Lead (Associate Director ) **Location** : Morristown,...bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for all ... and clinical trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of marketing and… more
- Sanofi Group (Framingham, MA)
- …diagnostic products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within ... **Job Title:** GRA Device Lead ( Director ) **Location** : Morristown, NJ,...Global Research and Development. Sanofi's global regulatory affairs (GRA) function is comprised… more