- Takeda Pharmaceuticals (Boston, MA)
- … Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Independently plan, execute ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of issues in creative ways. +… 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 ... for talent development within the team. Reporting to the Senior Director of Regulatory Affairs ,...compliance within LPE. Responsible for leading and developing the global RA team supporting LPE. Responsible for reviewing and… more
- Sumitomo Pharma (Boston, MA)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Takeda Pharmaceuticals (Boston, MA)
- …working groups to liaise effectively with cross-functional team members (Program Management, Global Regulatory Affairs , Regulatory Operations, Drug ... on cross-functional teams (Clinical, Global Patient Safety, Program Management, Global Regulatory Affairs , Regulatory Operations) to plan, generate,… more
- Takeda Pharmaceuticals (Boston, MA)
- …with US and EU standards and guidelines. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub ... life-changing therapies to patients worldwide. Join Takeda as the Senior Manager, Global Labeling Devices. You will...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Takeda Pharmaceuticals (Boston, MA)
- …with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates the ... process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- AbbVie (Waltham, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global ... and, if applicable, ensure direct reports follow requirements. + Ensures alignment of global regulatory strategies with Sr . Management. Under minimal… more
- Hologic (Marlborough, MA)
- …impact on our Global Supply Chain, Quality, and Regulatory Affairs initiatives. **Role Overview:** As the Senior Director of Operations Strategy & ... Sr Director, Operations Strategy & PMO Marlborough, MA, United States Join Our Team! Senior Director of Operations Strategy & PMO Leader Needed! Are you a… more
- Chiesi (Boston, MA)
- Sr . Director, Global Portfolio Strategy HIDO, Rare Date: Jan 17, 2025 Department: GRD Global Value & Access Job Type: Direct Employee Team: Mktg, Market ... monitor global market trends, patient demographics, competitor activities, and regulatory changes. Use this data to inform strategic decisions and adaptations +… more
- Sumitomo Pharma (Boston, MA)
- …internal company programs and external facing HCP and Payer interactions. The Sr . Director of Medical Affairs develops and maintains professional relationships ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma… more
- Hologic (Marlborough, MA)
- …Do** : + Develop and implement regulatory strategies ensuring top-tier global compliance. + Partner with quality, clinical affairs , R&D, marketing, and ... VP, Regulatory Affairs Marlborough, MA, United States...+ BS/BA degree or equivalent with 12+ years of senior leadership experience in regulatory roles. +… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager, Medical Affairs Technology and Digital Innovation** . **Job ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...the development, implementation, execution, and oversight of Medical Information/Medical Affairs digital services and innovative digital projects as well… more
- Sumitomo Pharma (Boston, MA)
- …approach to planning, executing, and problem solving + Working knowledge of current global regulatory requirements and guidelines for clinical trials. The base ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...highly motivated, and experienced individual for the position of ** Senior Clinical Project Manager, Medical Affair.** The Senior… more
- Merck (Boston, MA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Takeda Pharmaceuticals (Boston, MA)
- …career grounded in purpose 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 limited to Clinical Operations, Legal, Regulatory , Procurement, Patient Value Access and Safety. + Provides… more
- Merck (Boston, MA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... talented and dedicated colleagues while developing and expanding your career. The Senior Director ( Sr . Principal Scientist) has primary responsibility for the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …deliverables from assigned projects as required by the SDLC, and will support Regulatory Affairs ' efforts in creating submission materials for various ... (SDLC) processes for all Olympus SW development entities. The Senior Design Quality Engineer serves as a subject matter...a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs , etc. + Independent organizational and… more
- Edwards Lifesciences (Boston, MA)
- *We will consider candidates who qualify for either the ** Senior Principal Biostatistician** (Individual Contributor/ Subject Matter Expert) or the ** Senior ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more