- Takeda Pharmaceuticals (Boston, MA)
- …understands probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- Danaher Corporation (Putnam, CT)
- …Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory ... ideas into impact - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping… more
- Takeda Pharmaceuticals (Boston, MA)
- … vaccine programs in various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that ... product developmentprogramspreferred + Sound understanding of scientific principles and regulatory CMC requirements relevant to global vaccine development,… more
- Merck (Providence, RI)
- **Job Description** The Executive Director (ED) for Field Medical Affairs in the US understands our Company's corporate and products/portfolio strategies and ... work cross-functionally with the Global Medical and Scientific Affairs Therapeutic Area...in a highly matrixed environment is critical. The Executive Director provides strategic and tactical direction to the field… more
- Sumitomo Pharma (Providence, RI)
- …Strateg** **y (** **Hematology/Oncology** **)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...launch strategy and guide the tactical implementation of Medical Affairs plans. The Associate Director will also… more
- Sumitomo Pharma (Providence, RI)
- …, Medical Strategy (Prostate Cancer)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties… more
- Liberty Utilities (Fall River, MA)
- Manager, Rates and Regulatory Affairs Fall River, MA, US, 02720 **Our purpose is sustaining energy and water for life, and it is demonstrated in everything we do ... the East region. This position is responsible for all regulatory affairs and rates related functions in...in multiple jurisdictions. The Manager will support the Regional Director , on other regulatory matters and organizational… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Project Management and Strategic Planning - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will provide ... **How you will contribute:** + Defines, develops, and leads global strategies to maximize global regulatory...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... + Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of … more
- Takeda Pharmaceuticals (Boston, MA)
- …across the portfolio of PDT products. **How you will contribute:** + Serves as the global regulatory lead for one or more projects and and includes leadership of ... the Global ...the Global Regulatory Team (GRT) composed of core regulatory ...US FDA and provides support for regional and local regulatory affairs teams for interactions with international… more
- Takeda Pharmaceuticals (Boston, MA)
- …NRWS on cross-functional teams (Clinical, Global Patient Safety, Program Management, Global Regulatory Affairs (GRA), Regulatory Operations) to ... NRWS on nonclinical cross-functional teams, working in close partnership with Global Regulatory Affairs (GRA) and nonclinical subject matter experts (SMEs)… 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 ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... of my knowledge. **Job Description** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for… more
- Olympus Corporation of the Americas (Westborough, MA)
- …adequate support at global and regional levels. + Ensure the appropriate global regulatory requirements, are considered as part of due diligence and ... is maintained, well-organized and ready to be audited by global regulatory authorities / notified bodies. +...preferred. + Minimum of 15 year of directly related Regulatory Affairs experience; preferably a minimum of… more
- Chiesi (Boston, MA)
- … Director reports to the Head of Medical Affairs Hematology- Immunology Medical Director and is part of the Global Medical Affairs team supporting the ... consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded **B Corp Certification**...medical tactics under guidance from the Head of Medical Affairs related tactics to answer the unmet medical need… more
- Organon & Co. (Boston, MA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will...are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans.… more
- Takeda Pharmaceuticals (Boston, MA)
- …Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs . + Advanced knowledge of ... you and empower you to shine? Join us as Director , Quantitative Clinical Pharmacology (QCP) Lead in our Cambridge,... interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be… more
- Takeda Pharmaceuticals (Boston, MA)
- …Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs . + Advanced knowledge of ... external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical… more
- Sumitomo Pharma (Providence, RI)
- 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 ... highly motivated, and experienced individual for the position of **Senior Director , Commercial Strategy and Launch Lead, Heme/Onc.** **Job Duties and… more