- 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)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... medicine.Summary, Focus and Purpose:The Cardiovascular and Respiratory Clinical Research Director -has primary responsibility for planning and directing clinical research… more
- Cipla (Fall River, MA)
- …Massachusetts to support the launch of Cipla's respiratory business in the United States . Job Title Project Manager Organization Name InvaGen Pharmaceuticals ... committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs , regulatory affairs , quality assurance, procurement etc.… more
- Merck & Co. (MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… 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
- 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
- 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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ready to ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs -...US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and… 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 ... 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)
- …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
- Beth Israel Lahey Health (Boston, MA)
- …Summary: The Regulatory and Accreditation Program Manager reports to the Director , Regulatory Affairs . Manages the accreditation/ regulatory program ... **Job Type:** Regular **Time Type:** Full time **Work Shift:** Day ( United States of America) **FLSA Status:** Exempt **When you join the growing BILH team,… 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 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
