- Cytiva (Shrewsbury, MA)
- …to support effective design transfers and product launches.This position reports to the QA Senior Manager Site Quality Leader and is part of the Quality and ... Regulatory Affairs Team located in Shrewsbury, MA. and will be an on-site role.What you will do:Review and approve change control documentation (ECOs) to… more
- Sumitomo Pharma (Boston, MA)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Regulatory Affairs ** . The Senior ... Manager is part of the Global Regulatory Affairs (GRA) team based in the US and he/she will primarily function as a regional regulatory leader (RRL) and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project ... ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of responsibility include… more
- Medtronic (Boston, MA)
- …to innovation in a more connected, compassionate world. **A Day in the Life** The Senior Principal Regulatory Affairs Specialist will play a key role in ... develop the global regulatory strategy and support regulatory activities throughout the product lifecycle. The senior... regulatory requirements and partners with the international regulatory affairs group to support regulatory… more
- Cardinal Health (Boston, MA)
- …plans for product development programs and regulatory submissions. **_Job Summary_** The Manager , Regulatory Affairs directs regulatory affairs ... **_What Regulatory Affairs contributes to Cardinal Health_**...and provides insights to senior leadership regarding regulatory developments. The Manager leads a team… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Operations and Advocacy Projects Manager , Global Public Affairs **Location:** Cambridge, MA **About the job** We are an innovative global ... MA area_** **Main Responsibilities:** + This position is a manager role and covers a wide range of activities...projects. This position will support the VP/Head, Global Public Affairs , Specialty Care and the Global Public Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …and other complex diseases. The Global Regulatory Device Labeling Strategy Lead ( Senior Manager ) Plasma-Derived Therapies Business Unit (PDT BU) is a key ... drug and device. + Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team to ensure that regulatory… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Successful engagement in multiple initiatives simultaneously + Certification (such as Regulatory Affairs Professionals Society (RAPS)) + Prior project management ... The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of… more
- AbbVie (Cambridge, MA)
- …product(s) within Neuroscience and supports the Manager ( Senior Manager , Associate Director, Director (Global Regulatory Lead (GRL)), in the development ... (RSTP) for assigned on market products or those products in development. The Manager assists Regulatory Staff by identifying and gathering data needed to… more
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