- 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
- Merck & Co. (Boston, MA)
- …the Clinical Director at this level will be expected to lead a Product Development Team (PDT) through late-phase clinical development and into post-licensure ... DescriptionOur Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and… more
- Curia (Hopkinton, MA)
- …The Director , Analytical Development will provide technical leadership and lead a team of analytical scientists in support of biologics clinical development ... DIRECTOR , ANALYTICAL DEVELOPMENT in Hopkinton, MA Build your...has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over… more
- CSL Behring (Waltham, MA)
- …(eg protocol, TPP, etc.) generated from PST, CDT, SMT and related delivery teams. May lead discussion at Global Regulatory Forum (GRF) or with senior ... worldwide. Could you be our next Senior Manager Regional Regulatory Lead , Vaccines? The job is in...Director Head Regulatory . **Position Description** **Summary** - Regulatory leaders who support development of a global… 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
- Parexel (Boston, MA)
- …sponsor (ie: tasks and time per task contracted) and according to the assigned role ( Global Lead Physician GLP or Regional Lead Physician RLP). Medical ... needed with the support of the designated Senior Medical Director / Global Head of TA (as appropriate)...including medical review of serious adverse events. - Support regulatory safety reporting activities - Ensure client needs and… more
- Jet Aviation (Bedford, MA)
- …In the hangar, on the ground, and behind the scenes. Enabling global flight, with passion. **Position Summary** The Assistant Maintenance Manager is responsible ... manager also maintains current technical proficiency and education of aircraft and regulatory requirements. The assistant maintenance manager reports to the Lead … 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 , Global Regulatory Lead Oncology, you will define and lead global … more
- Takeda Pharmaceuticals (Boston, MA)
- …to 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 Director , Global Regulatory Lead Oncology you will set global regulatory strategy and lead … 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 (Cambridge, MA)
- …**How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter ... possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... GRA A&P SME for assigned products and projects. + Regulatory advisor as the "R" in the core Medical,...review, approval, and implementation + Product or project business lead for global CMRP at Takeda +… 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 ... for medical devices Due Diligence activities as applicable May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes the… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be… 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)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... post-approval strategies for assigned products as GRA CMC Product Lead . + Represents and contributes to Regulatory ,...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… 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)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … 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
