- Sanofi Group (Framingham, MA)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **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
- 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 (Boston, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs , Marketed Products in ... EU, Health Canada, and other international health authorities - Support regulatory team and Global Regulatory Lead (GRL) in preparations and timely delivery… 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)
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... awareness of recent in-class approvals. Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory Team (GRT) + Liaises with… 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
- 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
- AbbVie (Waltham, MA)
- …products with multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director, or Director), ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… 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
- ThermoFisher Scientific (Cambridge, MA)
- …on US and Canada + Ensure strategic pharmacovigilance support in the region to Regulatory Affairs , Medical Affairs , US Commercial function, and the broader ... the region. Assess current processes to ensure adherence to US safety regulatory requirements and where needed enhance and/or develop new processes while assuring… more
- Philips (Cambridge, MA)
- …key audiences. + Partner with clinical business teams, clinical science, clinical affairs , legal and regulatory to ensure compliance of marketing ... clinics, and radiology centers. **Your role:** As the Senior Product Marketing Manager for Radiology Informatics (RI), you will be responsible for new product… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …sales, regulatory , legal, I&A, commercial operations, patient advocacy, medical affairs , and patient value and access + Manage the product lifecycle from ... marketing strategies based on data insights, and ensuring compliance with regulatory requirements. The role requires a blend of strategic thinking, cross-functional… more
- Takeda Pharmaceuticals (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug development ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). + Minimum of 5… more
- Novo Nordisk (Lexington, MA)
- …writing, Regulatory , Data Science (statistics, pharmacometrics), Research and Early Development, Global Translation, Global Medical Affairs , Global ... About the Department Our East Coast Global Development Hub brings together the best minds...pharmacology aspects at internal and external meetings with eg regulatory authorities /advisory board meetings / governance boards /… more
- Sanofi Group (Cambridge, MA)
- …and you'll provide inspirational and strategic leadership to the US Medical Affairs Immunology team (Medical Directors, Medical Science Liaison Managers, MSLs & ... Medical Operations Manager ) by cultivating a culture of teamwork and collaboration...developing and retaining top talent. We are an innovative global healthcare company, committed to transforming the lives of… more
- Medtronic (Boston, MA)
- …from key functional groups (Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs , Legal, and European Clinical groups). + Identify ... only way to drive healthcare forward and remain a global leader in medical technology and solutions. Coronary &...+ Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials. + Strong written,… more