- Sanofi Group (Cambridge, MA)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ or Cambridge, MA **About the job:** The Manager , Global ... biological entities, vaccines. The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC in Cambridge, MA ... with the following requirements: Master's degree in Regulatory Affairs or related field plus 2...working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC Submissions Management ... requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead… more
- Philips (Cambridge, MA)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... patients around the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and… more
- Philips (Cambridge, MA)
- As a Regulatory Affairs Program Manager ,...minimum of 5 years' experience in regulatory affairs within the FDA regulated, global medical ... you will be an important member of the Philips Regulatory Affairs Centralized Services Team, committed to improving billions of lives worldwide. **Your role:** +… more
- ThermoFisher Scientific (Waltham, MA)
- …and pharmaceutical services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational ... within the team. Reporting to the Senior Director of Regulatory Affairs , the incumbent will serve as...compliance within LPE. Responsible for leading and developing the global RA team supporting LPE. Responsible for reviewing and… more
- Edwards Lifesciences (Boston, MA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... international regulatory environments....us and be part of our inspiring journey. The Manager , Medical Writing will provide guidance, develop, and lead… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to ... RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Operations; resolves a wide range of issues in creative ways. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Participates in strategic and operating planning activities in partnership with the Global Head of Clinical Affairs , in translating corporate and divisional ... are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + As a… more
- Boston University (Boston, MA)
- …documents, serving as an expert on tax compliance matters, maintaining currency on regulatory changes, leading special projects related to tax and regulatory ... with key departments such as the Investment Office and the Office of Global Programs Pay Rage: Minimum $78,000, Midpoint $117,000, Maximum $156,000. Salary is based… more
- ThermoFisher Scientific (Cambridge, MA)
- …cures for cancer. **Location/Division Specific Information** At Thermo Fisher Scientific, the Regulatory Affairs function plays a vital role in ensuring ... requirements while driving business growth. Join our dynamic Regulatory Affairs team and contribute to our...healthier, cleaner and safer. **Discover Impactful Work:** As **Sr. Regulatory Manager - Emerging Technologies & Cybersecurity**… more
- Sumitomo Pharma (Boston, MA)
- … of Regulatory Operations is responsible for managing all Regulatory Affairs activities involving compilation, publishing, distribution, and archiving of ... content, format, and quality requirements for electronic submissions, with input from Regulatory Affairs staff as needed. + Manages the external submission… more
- Harvard University (Cambridge, MA)
- …Resources for Trials IRB Reliance platform (SMART IRB) system, the Harvard Office of Regulatory Affairs and Research Compliance (ORARC), the HLC IRB, and the ... Administration Position Description: The Epidemiology Department is seeking a Regulatory and Compliance Manager for all PHACS-affiliated research… more
- Philips (Cambridge, MA)
- …+ This role will oversee a variety of different programs within Ultrasound Regulatory Affairs ; and will drive these programs from inception to completion. ... The Program Manager provides operational leadership of programs, and are...regulatory experience required with experience with US and global medical device regulations and submissions. Experience working in… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …more of the following Clinical Development functions in support of IT - Medical Affairs , Regulatory Affairs , Global Patient Safety, Clinical Operations, ... The Business Analysis & Operations Senior Manager will drive consistency across the Global...Quality. Experience working within and knowledge of GXP/GCP and regulatory ICH 6 guidelines. Strong knowledge of technologies such… more
- Olympus Corporation of the Americas (Westborough, MA)
- … Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... The training specialist will support the management of the global training process by collaborating with global ...development and use of reports in support of audits, manager accountability, and business partner requirements. + Organize and… more
- J&J Family of Companies (Boston, MA)
- …company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Local Trial Manager (LTM) actively contributes ... for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries....(LTM) may also perform the role of Clinical Trial Manager (CTM)/ Global Trial Lead (GTL) for single… more
- Abbott (Burlington, MA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... get on with their lives. **THE OPPORTUNITY** **Scientific Communications Manager ** We have an exciting opportunity for the right...for the right candidate to join our growing clinical affairs team within Abbott Heart Failure. The job purpose… more
- Olympus Corporation of the Americas (Westborough, MA)
- …the latest global regulations. + Collaborate closely with the Quality, Regulatory , R&D, Business Development, Medical & Scientific Affairs , IT, and ... Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) more
- embecta (Andover, MA)
- …components - is designed to support the varying needs of our diverse and global employees. The Senior Manager , Systems Engineering will provide leadership to ... embecta is a global diabetes care company that is leveraging its...peer leaders across R&D, Quality, Marketing, Clinical and Scientific Affairs , Operations, Medical Affairs and Regulatory… more