- 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
- J&J Family of Companies (Raritan, NJ)
- …as a single submission. Johnson & Johnson Innovative Medicine R&D is recruiting for an Senior Manager , Global Labeling Product Leader. This position is a ... agency regulations and interpretations accounting for new and changing government regulations. The Senior Manager , Global Labeling Product Leader will be… more
- Cole-Parmer (Franklin, MA)
- …FLSA Status (Exempt/Non-Exempt): Exempt FLSA Status (Exempt/Non-Exempt Position Summary: The Senior Manager , Global Product Management for Molecular ... Senior Product Manager , Job Title: Senior Product Manager , Global Product...line development in collaboration with Research & Development, Operations, Regulatory Affairs and Commercial teams. Implement appropriate… 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
- BD (Becton, Dickinson and Company) (Durham, NC)
- …**Summary:** Reporting to Medication Management Systems (MMS) Pharmacy Automation (PA) Regulatory Affairs Manager , the Senior Specialist, Regulatory ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...design and/or development in support of worldwide registrations. The Senior Specialist, Regulatory Affairs will… 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
- Abbott (Alameda, CA)
- …the way people monitor their glucose levels with our new sensing technology. This ** Senior Regulatory Affairs Manager - APAC** position will ... female executives, and scientists. **The Opportunity** This S **enior Regulatory Affairs Manager - APAC**...Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams… more
- Olympus Corporation of the Americas (Westborough, MA)
- … Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/ RA ) ... preparation of submission documents for product registration in selected global markets. The individual acts as an SME in...markets. The individual acts as an SME in international regulatory affairs and will provide international … more
- Abbott (Santa Clara, CA)
- …Opportunity** Our location in Santa Clara, CA currently has an on-site opportunity for a ** Senior Regulatory Affairs Manager - Transcatheter Mitral and ... Valve Repair Franchise. This individual will lead and coordinate global Regulatory Affairs activities including... regulatory strategies, submissions and product launches. The Senior Manager is responsible for estimating, allocating… more
- Novo Nordisk (Bloomington, IN)
- …for drug and combination products throughout the product lifecycle. The main responsibility of the Senior Regulatory Affairs Representative is to serve as a ... and help us make what matters. The Position The Regulatory Affairs department is accountable for the...and production activities + Maintain awareness of changes in global regulatory requirements for effective regulatory… more
- Medtronic (Los Angeles, CA)
- …with 90,000+ employees in more than 160 countries. A Day in the Life As Senior Regulatory Affairs Specialist, you will develop and implement medical device ... approvals from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you...regulatory agencies. + As an individual contributor, the Senior Regulatory Affairs Specialist is… more
- Hologic (San Diego, CA)
- …team setting. **Job Summary** + The primary responsibility of the Manager of Regulatory Affairs is to submit global regulatory submissions for ... here in San Diego, and are looking for a Regulatory Affairs Manager , responsible for...counterparts on complex projects. + Solid working knowledge of global regulatory requirements related to medical devices,… more
- Bausch Health (Bridgewater, NJ)
- …creates it-where your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical ... team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to...Authorities for assigned brand products + Liaise with country-specific regulatory affairs personnel for international submissions and… more
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