- Cardinal Health (Mansfield, MA)
- …ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other pharmaceutical regulatory requirements, preferred. + Working knowledge of ... as LabWare. + Possesses significant working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing. + Possess a… more
- Takeda Pharmaceuticals (Boston, MA)
- …BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. + 8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product ... development and registration strategies. You will be RA CMC member on Regulatory , Pharmaceutical Development, and Production project teams throughout clinical… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays ... with business objectives and drive the timely delivery of high-quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory … more
- Deloitte (Boston, MA)
- …to include: introducing new technologies like GenAI, AI/ML, and automation for pharmaceutical regulatory content or regulatory intelligence; Veeva RIM ... immigration sponsorship may be available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and generating… more
- Merck (Boston, MA)
- …Immunotherapy, International Regulatory Compliance, Leadership, Motivation Management, Pharmaceutical Regulatory Affairs, Regulatory Affairs Management, ... **Job Description** The Global Regulatory Liaison is responsible for developing and implementing... Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the Immunology therapeutic… more
- Takeda Pharmaceuticals (Boston, MA)
- …related field preferred. + Project management qualification. + 7-10 years of regulatory experience in the pharmaceutical /biotech industry. + Experience in global ... immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Operations, Compliance & Process Excellence is accountable for overseeing… more
- Cardinal Health (Boston, MA)
- …format, edit and compile paper and electronic documents related to the pharmaceutical industry regulatory submissions throughout each phase of drug development ... **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations uses specialized technology and knowledge to… more
- CGI Technologies and Solutions, Inc. (Burlington, MA)
- …for the organization's Quality Management Systems (QMS), ensuring compliance with pharmaceutical regulatory requirements (FDA, EMA, etc.). * Oversee the ... be responsible for managing the validation activities, quality assurance processes, and regulatory compliance for pharmaceutical projects. This role requires a… more
- Sanofi Group (Cambridge, MA)
- …record with a minimum of 1 year (3+ years preferred) of regulatory experience, preferably within the pharmaceutical /medical device/biotech industry + Knowledge ... **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to… more
- Sanofi Group (Cambridge, MA)
- …and responsibilities. **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape the… more