- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs ( RA ) CMC project representative to the CMC ... support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence,… more
- Merck & Co. (North Wales, PA)
- …other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior -level and first-line ... teams both as a direct manager and a second line manager (ie, managers of managers)Demonstrated collaboration with senior cross-functional leadership in… more
- Pfizer (Groton, CT)
- The ** Senior Manager , Global Labeling Lead (GLL)** has overall accountability for the development and execution of global labeling strategy for their ... and competitor label assessments + Act as the primary labeling representative on Global Regulatory Strategy Teams, Submission Working Groups, and other relevant… 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
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy US and Canada ... products with multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director, or Director),… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …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
- embecta (Parsippany, NJ)
- …and interaction with key internal customers specifically R&D, Quality Systems, Regulatory Affairs , Operations Quality, and Post Market Surveillance teams ... and goals. You will be a member of the global quality senior leadership team and support...with cross-functional teams to foster continuous improvement. **_RESPONSIBILITIES:_** The Senior Manager of Design Assurance will be… more
- Abbott (Abbott Park, IL)
- …R&D, marketing, legal, regulatory affairs , operations, quality, HR, government affairs , and finance. The senior manager also maintains budget ... We are currently seeking an experienced senior manager to join our Public Affairs team...Affairs team in Lake Bluff, IL. The Public Affairs team has global responsibility for public… more
- Amazon (Bellevue, WA)
- …trade compliance, risk management, supply chain operations, product classification, or regulatory affairs - Experience designing and implementing scalable ... scale at Amazon. Key job responsibilities - Develop Strategic Frameworks: Define global strategies to meet diverse regulatory requirements across countries and… more
- AbbVie (Waltham, MA)
- …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 (Weston, FL)
- …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
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …guidance from the Regulatory Affairs , Advertising and Promotion Director. The Senior Manager Regulatory Affairs , Advertising and Promotion will ... Senior Manager position within the Regulatory Affairs department requires the ability to...typical day might include:** + Management of US and Global (if applicable) regulatory activities associated with… 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
- Medtronic (Irvine, CA)
- …reports, and ensuring that our product technical documentation is current and accurate. ** SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR** In the ... compassionate world. **A Day in the Life** The Sr Regulatory Affairs Specialist will play a key...Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards +… more
- Liberty Utilities (Merrick, NY)
- Senior Manager , Rates and Regulatory Affairs Merrick, NY, US, 11566 **Our purpose is sustaining energy and water for life, and it is demonstrated in ... how we achieve it.** **Purpose** The Senior Manager Rates and Regulatory Affairs ...America and internationally, we are continually demonstrating our "Think Global , Act Local" business model.** **What we offer** Company… more
- Amgen (Washington, DC)
- …worldwide. It's time for a career you can be proud of. **US Regulatory Affairs Lead - Senior Manager ** **Live** **What you will do** Let's do this. ... regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve...with a focus on patient safety + Represent regional regulatory affairs as a member of the… more
- J&J Family of Companies (Titusville, NJ)
- …Belgium; Allschwil, Switzerland; High Wycombe, Great Britian; Leiden, Netherlands) **Purpose:** The Senior Manager , RA Submissions is a member of ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...submission related work based on area of responsibility. The Senior Manager , RA Submissions makes… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Bausch Health (Bothell, WA)
- …creates itwhere your skills and values drive our collective progress and impact. The Manager Regulatory Affairs provides direct support to Solta operations ... Collaboration + Act as the key liaison between the global regulatory affairs team and... status reports to senior management, highlighting regulatory achievements and potential risks. Global … more
- Medtronic (Minneapolis, MN)
- …innovation in a more connected, compassionate world. **A Day in the Life** ** SENIOR REGULATORY AFFAIRS SPECIALIST** In collaboration with leading clinicians, ... and web-based applications that directly affect and improve patient's lives. The Senior Regulatory Affairs Specialist develops strategies for worldwide… more
