- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Merck & Co. (Boston, MA)
- …and executing integrated development plans that align clinical, medical affairs , commercial, manufacturing, regulatory , analytical, and epidemiological ... and pipeline products to produce safe, effective, innovative medicine.The Clinical Director is responsible for protocol development and medical/ scientific oversight… more
- CSL Behring (Waltham, MA)
- …approval in one key region (EU, US , Japan) -Experience working in Regulatory Affairs with agency interaction responsibility with at least 1 health authority. ... (PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ... to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek...cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities… more
- Sumitomo Pharma (Boston, MA)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US ....I-IV Research & Development Activities + As a Regional Regulatory Lead, manage regional ( United States… more
- Sumitomo Pharma (Boston, MA)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US ....mentoring. **Job Duties and Responsibilities** + As a Regional Regulatory Lead, manage regional ( United States… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... to prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ... critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs...different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs ( US RA AdPromo)...different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles… 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 ... of all assigned programs/products as the internal expert on US Codes, guidance, and industry standards pertaining to prescription...GRA A&P SME for assigned products and projects. + Regulatory advisor as the "R" in the core Medical,… 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 ... and operational oversight of custom analytics deliveries from Global Regulatory Affairs involving Business Intelligence solutions and related semantic layer… more
- United Therapeutics (Boston, MA)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... or pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… more
- Danaher Corporation (Boston, MA)
- …compliance, driving innovation and excellence in the Biopharma sector. This position reports to the Director , Regulatory Affairs and is part of the Global ... m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Takeda Pharmaceuticals (Boston, MA)
- …as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as ... GRA CMC Product Lead. + Represents and contributes to Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical development and… more
- Beth Israel Lahey Health (Boston, MA)
- …Summary: The Regulatory and Accreditation Program Manager reports to the Director , Regulatory Affairs . Manages the accreditation/ regulatory program ... management support. Coordinates the dissemination of performance assessment and regulatory updates to appropriate medical center staff. + Ensures that… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a...the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …best of my knowledge. **Job Description** **About the role:** Join Takeda as the Senior Director , US Medical Affairs - Head of Rheumatology in Cambridge, MA. ... This is a critical role within the US Medical Affairs (USMA) organization that reports...coaching/mentorship to team managers, as appropriate. Further, the Senior Director will contribute to the medical unit insights, including… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …of my knowledge. **Job Description** **About the role:** Join Takeda as the Medical Affairs Senior Director , Oncology - Colorectal Cancer. You will champion new ... products and on Takeda therapeutics positioned in the disease states . Maintain and continue to build the highest level...to Takeda. You will report to the Head of US OBU Medical Affairs and the role… more
- Pfizer (Cambridge, MA)
- …compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or ... **ROLE SUMMARY** As the US Senior Medical Director , mRNA Vaccines,...any location outside of the United States . Relocation assistance may be available… more
