- Merck (Boston, MA)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... drive our strategic priorities. The Director, Principal Scientist | Regulatory Affairs Liaison is responsible for development...a new therapeutic area for our company; where no regulatory guidance exists; where the program is… more
- J&J Family of Companies (Boston, MA)
- Associate Director, CMC Regulatory Affairs - 2406221330W **Description** Johnson & Johnson is recruiting for an Associate Director, CMC Regulatory Affairs ... and is in alignment with the strategies of global regulatory affairs , the therapeutic area, commercial, regional...senior member of the department. + Reviews CMC regulatory dossiers for global submissions throughout the product lifecycle… more
- Highmark Health (Boston, MA)
- …Description :** The Intern will provide day-to-day and project support to the Regulatory and Legislative Affairs Department. This includes, but is not limited ... generation of diverse business professionals. To that end, the program will provide hands-on training and experience in the...for action. The intern will provide assistance to the Regulatory and Legislative Affairs Department by providing… more
- Takeda Pharmaceuticals (Lexington, MA)
- …where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval strategies for assigned products as ... GRA CMC Product Lead. Represents and contributes to Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical...the GRA CMC team, you will report to the Senior Director GRA CMC and work cross functionally across… more
- Actalent (Boston, MA)
- …Reg Dev and CMC leads, create content plans and submission timeline for regulatory submissions o Plan kick-off meetings and comment resolution meetings for major ... plans o Coordinate cross-functional review and approval cycles for regulatory documents. * Maintain regulatory calendar/book of...relationships and serve as a key point person for program team members on matter related to submission management… more
- Veterans Affairs, Veterans Health Administration (West Roxbury, MA)
- …management to Veterans in both the Lung Transplant Program and the VAD Program . The incumbent serves as the Senior Social Worker in the Acute ... to discharge. The incumbent is administratively responsible for managing consults and tracking program related data. The Senior Social Worker selected for this… more
- Boston University (Boston, MA)
- …Residence Life program that aligns with the Division of Student Affairs ' mission, values, and strategic priorities. Ensure that all residential programs and ... , the Director of Residence Life reports to the Senior Associate Dean of Students and oversees a large...with trends and best practices in higher education, student affairs , and residence life. Make recommendations for program… more
- Takeda Pharmaceuticals (Boston, MA)
- …and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Head of Evidence Generation, Global Medical ... Affairs Oncology. You will work cross-functionally with but not...cross-functionally with but not limited to Clinical Operations, Legal, Regulatory , Procurement, Patient Value Access and Safety. + Provides… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. POSITION ACCOUNTABILITIES: + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... **Job Description** About the role: Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Veterans Affairs, Veterans Health Administration (West Roxbury, MA)
- …academic affiliation relationships, to name a few. Works closely with senior management and others in implementing and evaluating policies, plans, and ... to complete an online onboarding process Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs … 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 ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead, GI &...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Boston, MA)
- …of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global ... application is true to the best of my knowledge. **Job Description** Senior Technical Regulatory Advisor - Pharmaceuticals ( Senior /Executive Director)… 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 achieve a ... all regulatory sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations and future strategy of the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- Microsoft Corporation (Burlington, MA)
- …and grow, our team may be the place for you. We are looking to hire a Senior Program Manager to join our team. Microsoft's mission is to empower every person and ... regulatory oversight and documentation of the Medical Device program . + Serve as a SME for Engineering and...+ Experience working on radiology and imaging devices + Regulatory Affairs Certification (RAC) Devices, lead ISO13485… more
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience or Advanced degree (PharmD, PhD, MD ... regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed. + May lead Health Authority...initiation + Ensure that regulatory messaging for regulatory submission documents is aligned with program … more
- AbbVie (Waltham, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory ... regarding work processes or operational plans and schedules to achieve the program objectives established by senior management. Advances the organization's goals… more
- Eversource Energy (Westwood, MA)
- **Our Team** Eversource is looking for a ** Senior Program Manager, Strategic Project Development, Transmission** located in **Hartford, CT or Westwood, MA\.** ... and budgets in the conceptual phase prior to execution + Interacts regularly with Regulatory Affairs , Environmental Affairs , and Energy Efficiency to develop… more
- Novo Nordisk (Lexington, MA)
- …Modalities department Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will ... you ready to make a difference? The Position The Senior International Medical Director serves as a subject matter...+ Work with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- … management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive Director and ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director, GRA CMC Pharmaceuticals Development Portfolio Lead where...Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will… more