- 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
- 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
- Parexel (Boston, MA)
- …(ie, tasks and time per task contracted) and according to the assigned role ( Global Lead Physician or Regional Lead Physician). **Medical Expertise** and ... transform scientific discoveries into new treatments. From clinical trials to regulatory , consulting, and market access, our therapeutic, technical, and functional… more
- Curia (Boston, 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
- 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)
- …**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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ready ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs -...Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related… 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)
- …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)
- …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
