- Beckman Coulter Diagnostics (Miami, FL)
- …be a part of the Global Process Owner (GPO) Team and report to the Senior Manager of Global Quality responsible for overseeing various Global Quality ... Device Regulation (IVDR) as well as all other applicable global regulatory requirements.Maintain oversight, tracking, metric reporting...not required but training and certificates in quality or regulatory affairs would be a plus (eg… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As an Senior Manager , Global Regulatory Affairs , Precision Medicine, you will ... regulatory strategy in alignment with the drug global regulatory strategy and in compliance with...Parsippany, NJ or Foster City, CA. **Responsibilites:** + Represent Regulatory Affairs Precision Medicine or Dx … more
- Integra LifeSciences (Princeton, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The Senior Global Product Manager - Upstream for Integra's Surgical ... and evaluations + Monitors product development progress with engineering, manufacturing, regulatory affairs and related departments to ensure product line… more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC- RA , labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of ... and GMP related submissions and inquiries. + Represents CMC RA in project team meetings and provides regulatory...and perspective to the cross-functional team in conjunction with global regulatory lead(s). + Prepare, coordinate and/or… more
- Takeda Pharmaceuticals (Boston, MA)
- …pertaining to pharmaceutical drug and device. + Serve as the expert for device labeling on the global Regulatory Affairs ( RA ) Sub team and Global ... Global Regulatory Device Labeling Strategy Lead ( Senior Manager ) Plasma-Derived Therapies Business Unit (PDT...PDT BU products, in collaboration with the Head of Global RA Marketed Products and Labeling. +… more
- Sumitomo Pharma (Frankfort, KY)
- …Regulatory Affairs ** . The Senior Manager is part of the Global Regulatory Affairs (GRA) team based in the US and he/she will primarily ... regional regulatory leader (RRL) and support the global regulatory leader (GRL) as requested. This...Ideally with a minimum of 4 years focused in regulatory affairs + Experience contributing to electronic… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs , Chemistry, ... affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand...documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA… more
- Stryker (Mahwah, NJ)
- …some workplace flexibility. As the ** Senior Manager , Regulatory Affairs ** , you will lead and coordinate global regulatory activities including ... We are currently seeking a ** Senior Manager , Regulatory Affairs ** to...global medical device regulations including direct experience with regulatory submissions associated with US and EU Class II/III… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for ... exercises. + Collaborates with colleagues across the global RA CMC organization, Gilead regulatory affairs , and affiliates on internal meetings and… more
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