- Olympus Corporation of the Americas (Westborough, MA)
- …audit responses, etc.). Can serve as a backup to the Global Director Quality Compliance: External Regulatory Communications. Review and provide guidance ... Quality / Regulatory compliance communications to ensure compliance of the Global Quality System with applicable regulatory requirements and with the… more
- Takeda Pharmaceuticals (Columbus, OH)
- …and operational activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs. + Partners with internal ... stakeholders and external CRO partners such as Global Regulatory Compliance, Global Labeling,...matters related to global labeling compliance and quality . + With the Director of … more
- Amgen (Washington, DC)
- …and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What you will do** Let's ... Director supporting products in Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global...the position. As an organization dedicated to improving the quality of life for people around the world, Amgen… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Therapy Area Head, Global Regulatory Medical Writing (USA, Remote) Date: Nov 17, 2024 Location: Parsippany, United States, New Jersey, 07005 ... to live better, healthier lives. **The opportunity** As a ** Director , in Global Regulatory Medical...offer clear guidance, leadership, accountability for the preparation of quality , fit-for-use clinical regulatory documents for various… more
- Lilly (Indianapolis, IN)
- …and enable effective decision-making related to molecule development. + Consult on global regulatory strategy, advise on IND/CTA content including gap analysis ... Lilly and LRL operates. The **Senior Director /Executive Director ** is responsible for managing all Regulatory ...Quality . + Core work hours, Monday-Friday + Flexible global locations with preference for London UK, Indianapolis IN,… more
- Novo Nordisk (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions ... The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work... strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... regulatory individuals to ensure timely delivery of high quality of regulatory dossiers and strategies according...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Regulatory Medical Writing & Data Transparency Date: Oct 31, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva ... difference, and new people to make a difference with. **The opportunity** The Senior Director in Global Regulatory Medical Writing & Data Transparency… more
- Danaher Corporation (Chicago, IL)
- …the Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory ... and improve human health. This position is part of Quality and Regulatory Affairs located in Fargo,...ensuring accuracy, completeness, and timeliness. + Monitor and interpret global regulatory requirements and trends, provide strategic… more
- Merck (North Wales, PA)
- …for projects of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... **Job Description** Under general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and… more
- BeiGene (Emeryville, CA)
- …assess corrective measures for internal and external GxP Compliance audits. + Work with Global Quality Compliance and Regulatory teams to ensure accuracy of ... The incumbent will: + Lead the activities of the Global Regulatory Affairs SOP Committee regarding life-cycle...provide senior management with reports on the progress of quality initiatives. + Support the global compliance… more
- AbbVie (Pleasanton, CA)
- …and strategy (eg, Medical Device Regulation) for medical devices to support global regulatory plans, due diligence, integrations, and divestitures. Acts as ... Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director of Regulatory Affairs - Body Contouring...on regulatory policy issues. Supports and develops global regulatory teams to meet company objectives.… more
- Herbalife (Torrance, CA)
- Director , Global Regulatory Affairs - Corporate Category: Legal Position Type: Regular Full-Time External ID: 14913 Location: Torrance, CA, United States ... Now **Overview** **THE ROLE:** Reporting to the VP of Global Regulatory & Post-market Safety Affairs, this...products. + Ability to successfully contribute to improving the quality of internal regulatory policies, processes, programs… more
- Novo Nordisk (Lexington, MA)
- …make a difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... medicines. You will lead a global regulatory team to... strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may... Labeling Operations and Compliance Leads to produce high quality labeling documentation. + Establishes Processes and Best Practices:… more
- AbbVie (Irvine, CA)
- …AbbVie systematically defines quality objectives, both strategic and applicable regulatory requirements. Director , Safety, Regulatory and Medical Affairs ... affairs function regulatory requirements. Proactively monitor and interpret the external global regulatory environment for regulatory issues, trends, and… more
- Charles River Laboratories (Northridge, CA)
- …at Cell Solutions, you will make a difference every day. **Job Summary** The Director , Regulatory Affairs and Quality Assurance is responsible for ensuring ... and approve employee training and competency programs to ensure compliance with all regulatory requirements. * Communicate all quality related issues and trends… more
- Global Foundries (Santa Clara, CA)
- …to shape their markets. For more information, visit www.gf.com . Job Summary: The Director of Global Benefits and Mobility is responsible for the strategic ... aligned with the company's overall business objectives . The Director will work closely with HR leaders, finance, legal,...years in a leadership capacity. + Deep understanding of global benefits trends, mobility practices, and regulatory … more
- Dollar Tree (Chesapeake, VA)
- …and external legal consultants, lab services, Finance, Imports/ Logistics, Private Brands and Global Sourcing teams. The Director will focus on hardline and ... and Compliance team members, Sourcing Coordinators and Merchants as it relates to regulatory and quality requirements. d) Drive knowledge and awareness of safety… more
- Simplot (Boise, ID)
- Senior Director Global Food Safety & Quality Apply now...Safety & Quality leads and directs the global Food Safety, Quality and Regulatory ... and other enterprises related to agriculture. **Summary** The Senior Director Food Safety & Quality is a...across our global footprint for Food Safety, Quality and Regulatory . This includes (but not… more
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