- 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 ... + A seasoned, experienced professional with a full understanding of Regulatory Operations ; resolves a wide range of issues in creative ways. +… more
- Takeda Pharmaceuticals (Boston, MA)
- … Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to ... regulatory sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations and future strategy of… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …Development functions in support of IT - Medical Affairs , Regulatory Affairs , Global Patient Safety, Clinical Operations , BioStats & Data Management, ... The Business Analysis & Operations Senior Manager will drive consistency across the Global Development (GD) IT team & IT community. This role will be a key team… more
- Sanofi Group (Cambridge, MA)
- **Job title:** Manager, Global Regulatory Affairs CMC + Location: Bridgewater, NJ or Cambridge, MA **About the job:** The Manager, Global Regulatory ... biological entities, vaccines. The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country… more
- Merck (Boston, MA)
- … Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our ... model to maintain best-in-industry regulatory compliance. The Vice President Regulatory Affairs , General Medicine is accountable for: + Directing and… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in ... data and information. + Actively participates on the PDT Global Regulatory Affairs Leadership Team,...data that will resolve or simplifies complexity between commercial, operations , and strategy. + Resilient and comfortable working through… more
- Philips (Cambridge, MA)
- …right fit if:** + You have a minimum of 10 years' experience working in Regulatory Affairs and Quality/Quality Operations within the FDA regulated Medical ... The Director of Regulatory Affairs & Quality will lead...and/or Quality teams. + You have extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485,… more
- Merck (Boston, MA)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** Our Regulatory Affairs team bring new medical... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or… more
- Merck (Boston, MA)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** Our Regulatory Affairs team bring new medical...with a growth mindset. **Position Description:** The Senior Director, Global Regulatory Lead, is responsible for development… 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
- 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....and resolving project-related issues with cross-functional partners (eg, Clinical Affairs , Quality, R&D, etc.) + Act as a technical… more
- Orchard Therapeutics (Boston, MA)
- …cross-functional teams - Medical Communications / Publications - Regional and global operations teams - Cross-functional teams (Patient Advocacy, Diagnostics, ... grant funding requests . Medical Information / Medical Affairs functional and departmental operations - Development...Clinical Development, Regulatory - Global internal teams (Boston, London,… more
- AbbVie (Waltham, MA)
- …scientific and medical activities with internal stakeholders (ie commercial, clinical operations , discovery, statistics, regulatory , etc ) as they relate ... assist with the scientific review, development, execution and communication of affiliate/area/ global medical affairs sponsored or supported clinical research… more
- AbbVie (Boston, MA)
- …scientific and medical activities with internal stakeholders (ie commercial, clinical operations , discovery, statistics, regulatory , etc.) as they relate to ... medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions (HCP's,… more
- Sumitomo Pharma (Boston, MA)
- …of Regulatory Operations is responsible for managing all Regulatory Affairs activities involving compilation, publishing, distribution, and archiving of ... and experienced individual for the position of Senior Manager, Regulatory Operations . For assigned projects, the Senior...and quality requirements for electronic submissions, with input from Regulatory Affairs staff as needed. + Manages… more
- Merck (Boston, MA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations ) for the ... the organization between departments and therapeutic areas as part of a global team. **Primary responsibilities for the Principal Scientist include the following:**… 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 ... protocols and materials, protocol modifications and reportable information, as well as regulatory compliance and operations + Serving as the intermediary between… more
- Takeda Pharmaceuticals (Boston, MA)
- … global brand strategy, incorporating cross-functional strategies (eg Commercial, Regulatory , and Region/country medical partners, and others, as appropriate). + ... Lead development and execution of the global medical affairs (GMA) strategic and tactical...patient strategy, digital). + Work with the GMUH & global medical strategy & operations (GMS&O) lead… more
- Sanofi Group (Cambridge, MA)
- …and market access on therapeutic solutions to support patients' needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's ... experience highly preferred + Experience in pipeline, clinical development and/or medical affairs on a global or regional level (commercial experience a… more
- Sanofi Group (Cambridge, MA)
- …and market access on therapeutic solutions to support patients' needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's ... experience highly preferred. + Experience in pipeline, clinical development and/or medical affairs on a global or regional level (commercial experience a… more