- ZOLL Medical Corporation (Chelmsford, MA)
- …a purpose.Join our team. It's a great time to be a part of ZOLL!Job SummaryThe Senior Regulatory Affairs Program Lead is responsible for managing the ... with cross-functional stakeholders to ensure regulatory compliance is met. The Senior Regulatory Affairs Program Lead will oversee the technical… more
- Medtronic (Boston, MA)
- …to innovation in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Program Manager will manage implementation regulatory ... Robotics Surgical Technologies (RST) portfolio. The mission of Global Regulatory Affairs is to influence the ...the development and execution of Robotic Surgical Technologies (RST) regulatory program strategies to enable business strategy… more
- Philips (Cambridge, MA)
- The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are ... regulatory compliance. + Reporting to the Head of Regulatory Affairs for AM&D, you will communicate...to participate in our comprehensive Philips Total Rewards benefits program , which includes a generous PTO, 401k (up to… more
- Harvard University (Cambridge, MA)
- …protected by law.Job Summary:The Senior Manager for Intergovernmental Policy and Regulatory Affairs for Harvard Public Affairs and Communications (HPAC) ... and its operations. The Senior Manager for Intergovernmental Policy and Regulatory Affairs brings significant knowledge of state and municipal regulatory… more
- Bausch + Lomb (Boston, MA)
- …the life cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs , R&D, TechOps and Supply Chain as appropriate in a ... company functions during Regulatory Authority inspections. + Serve as Regulatory Affairs representative on facility/site Local Change Management Boards. +… more
- Philips (Cambridge, MA)
- …role you have the opportunity to** Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory ... US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. **Your role:** + Serve as RA Representative on project teams,… more
- Philips (Cambridge, MA)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new...to participate in our comprehensive Philips Total Rewards benefits program , which includes a generous PTO, 401k (up to… more
- Takeda Pharmaceuticals (Boston, MA)
- …for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in the PDT R&D ... and information. + Actively participates on the PDT Global Regulatory Affairs Leadership Team, providing input on...all development programs and works collaboratively with the Global Regulatory Program Strategy team to bring any… more
- Astellas Pharma (Westborough, MA)
- …eligible positions + Long Term Incentive Plan for eligible positions + Referral bonus program \#LI-TR1 Category Regulatory Affairs CMC Astellas is committed ... ** Regulatory Manager, Regulatory Affairs ...with functional peer groups internally and externally, occasionally with senior management. + Advises local teams on regulatory… more
- Philips (Cambridge, MA)
- ** Senior Director of Clinical Affairs ** Delivers clinical knowledge, experience and expertise across the whole value chain from ideation to end-of-life. Focus in ... topics to support strategy development and strategy execution. + Build Clinical Affairs , Market Access and outcomes research capability and governance (together with… more
- Takeda Pharmaceuticals (Lexington, MA)
- …life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will develop and lead the execution ... As part of the Regulatory CMC team, you will report to a Senior Director and work with stakeholders across the business. **How you will contribute:** + As… 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
- CVS Health (Boston, MA)
- …a share of special clinical investigations and research as requested by the Senior Medical Director, Medical Affairs . These projects can include brief reviews ... a share of special clinical investigations and research as requested by the Senior Medical Director, Medical Affairs . These projects can include brief reviews… more
- Takeda Pharmaceuticals (Boston, MA)
- …Therapeutic Area (TA) including hiring of Global Medical Affairs (GMA) professionals covering different therapeutic indications and devising/implementing ... with overall GM strategy and cross-functional partners in R&D and GPD (Clinical, Regulatory , GEO, PV, GPLS, HEPA, MPD, and Regions).** **Serves as member of the… 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
- Philips (Boston, MA)
- …of related disciplines. + Bachelor's degree with 5+ years of related experience in regulatory affairs engineering; or a Master's degree with 3+ years of related ... experience in regulatory affairs engineering. + You must be...to participate in our comprehensive Philips Total Rewards benefits program , which includes a generous PTO, 401k (up to… 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
- Sanofi Group (Cambridge, MA)
- …Therapeutic Area (TA) Head, Global Business Unit (GBU) Head and up to the Global Regulatory Affairs (GRA) Leadership Team (LT) as needed. The GRL is the primary ... is the single GRA point of contact for the program and represents GRA at the GPT / GBT...pharmaceutical/biotechnology experience, including at least 10 years of relevant Regulatory Affairs experience (regionally and global), in… more
- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global), in early and ... 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