- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Manager , Global Regulatory Affairs CMC Submission Management where ... manage multiple and simultaneous projects. As part of the Regulatory Affairs CMC team, you will report...Collaborating with cross-functional teams to develop project plans for global regulatory submissions (IND/ IMPD/ CTA/ MAA)… 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 Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are ... compliant by preparing comprehensive global regulatory strategies for new devices and...regulatory compliance. + Reporting to the Head of Regulatory Affairs for AM&D, you will communicate… 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
- Deloitte (Boston, MA)
- …relevant consulting experience. + 4+ years of Life Sciences industry experience in the regulatory affairs function to include: + Regulatory operating model ... digitally enabled, equitable future of health As a Senior Manager in our AI & Data team are expected...+ Veeva RIM and/or QMS implementation + Understanding of regulatory data and regulatory filing requirements +… more
- Deloitte (Boston, MA)
- …relevant consulting experience. + 4+ years of Life Sciences industry experience in the regulatory affairs function to include: + Regulatory operating model ... a digitally enabled, equitable future of health As a Manager in our AI & Data team, you will...+ Veeva RIM and/or QMS implementation + Understanding of regulatory data and regulatory filing requirements +… more
- ICON Clinical Research (Boston, MA)
- …to support scientific communication, medical education, and knowledge dissemination across global markets. ** Manager , Scientific Affairs - Hybrid** We ... Manager , Scientific Affairs - Hybrid ICON plc...scientific expertise and support to cross-functional teams, including medical affairs , marketing, and regulatory affairs .… more
- Google (Cambridge, MA)
- … Affairs and Public Policy team, you'll be part of a diverse global government affairs team, working across regions, product areas, and functions. You'll ... them. Preferred qualifications: + Experience in government relations, political campaigns, public affairs , external affairs in the northeast region. + Experience… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. POSITION ACCOUNTABILITIES: + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... Description** About the role: Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Boston, MA)
- …on submissions within their responsibilities. + Serves as the lead interface between PDT global regulatory affairs , global subject matter experts, ... lead for one or more projects and coordinates the Global Regulatory Team (GRT) meetings composed of...related to assigned programs and supports regional and local regulatory affairs teams with health authority interactions.… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs SOPs and processes. + Coordinate with Pharmacovigilance, Quality and Regulatory Affairs to respond to external audits and requests from external ... **About the role:** You will manage the operational conduct of Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR) and Externally… 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
- Takeda Pharmaceuticals (Boston, MA)
- …Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs , Finance, Safety Statistics, etc.) contributing to aggregate ... and support of audits and inspections. + Liaises with Regulatory Affairs to coordinate synchronization of aggregate...prioritize individual and teamwork loads. + Expert knowledge of Global regulatory requirements. + Experience in vendor… 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
- Fresenius Medical Center (Waltham, MA)
- …device manufacturing industry or pharmaceutical industry. Experience in quality assurance, regulatory affairs , compliance preferred. + 3+ years of experience ... Ensure the quality measurement system is consistently applied across global sites and validated/verified per regulatory requirements....as a Manager preferred. Strong project management skills. + Demonstrated ability… more
- Integra LifeSciences (Boston, MA)
- …partnering across the business and human resources team as a key partner to the global quality assurance and regulatory affairs organization and operate as a ... Manager is a member of the HR Global Operations, Quality and Regulatory team who...exciting opportunity to influence the integration of quality assurance, regulatory affairs and operations to drive a… more
- Philips (Cambridge, MA)
- …Economics, Market Access, and Reimbursement Department. **Your role:** + Partner with Global Clinical and Medical Affairs , Marketing, and Market Access teams ... within clinical trials to enable negotiations, reimbursement, and patient access with global payers and regulatory decision makers. Support the development of… more
- Sumitomo Pharma (Boston, MA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...highly motivated, and experienced individual for the position of ** Manager , Pharmacovigilance Scientist.** The Manager , Pharmacovigilance Scientist… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …synthetic molecules, biologics, cell therapies, and other drug modalities. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global ... of your future at Takeda. Join us as a Manager of Statistics in our Cambridge, MA office. Here,...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more