- Pall (Miami, FL)
- …the Danaher Business System which makes everything possible. Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets ... impact - innovating at the speed of life.As a global leader in high-tech filtration, separation, and purification, Pall...or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance… more
- Cytiva (Pensacola, FL)
- …in line with certification requirements and customer expectations.This position reports to the Quality Director Filtration - Membrane Sites and leads both the ... do: Quality Leadership & Compliance: Serve as the Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance,… more
- Aldevron (Miami, FL)
- …audit results.Serve as the site's primary contact with both customers and regulatory agencies regarding quality /compliance issues and Negotiate Quality ... product manufacturing with incoming Quality Management Systems, Quality Assurance and regulatory audits required.Bachelor of...that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences,… more
- Danaher Corporation (Port Washington, NY)
- …System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory Compliance ... - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall...or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance… more
- Bayer (Whippany, NJ)
- …brilliant and diverse minds to make a real difference, there's only one choice.** ** Director , Global Regulatory Strategist, CGT Combination Products** The ... Director , Global Regulatory Strategist, Cell & Gene Therapy...MDR, Declarations of Conformity, CE Marking, ISO 13485, FDA Quality System Regulations, Design Control, 510(k), PMA etc.), particularly… 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
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and ... to stakeholders in development, manufacturing, and quality + Ensures that global CMC regulatory commitments are defined based on approved submissions for… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk...nuances and requirements. - Understanding of scientific principles and regulatory / quality systems relevant to drug development. -… more
- Ascendis Pharma (Princeton, NJ)
- …team. This is an exciting opportunity to join a rapidly growing innovative company. The Director , Global Regulatory Strategy and Policy Advisor, will be at ... and guidance will play a pivotal role in shaping outcomes that matter. The Director , Global Regulatory Strategy and Policy Advisor, will work closely… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategy and coordinating life cycle activities across the portfolio of PDT products. The Global Regulatory Lead, Director , in PDT R&D: + Serves as the ... global regulatory lead for one or more projects and and...cross-functional sub teams and working groups. + Creates high quality , complaint regulatory documents (eg, BLAs, INDs,… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead ... (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area. The GRL is the accountable… more
- Gilead Sciences, Inc. (Foster City, CA)
- …regardless of where they live or their economic status. **POSITION OVERVIEW:** As a Director , Early Oncology Global Regulatory Affairs, you will develop and ... Oncology regulatory strategies in alignment with the global regulatory strategies in collaboration with Franchise...+ BA/BS with 12+ years' relevant experience. + Extensive regulatory , quality , compliance or related experience in… more
- Kelly Services (South San Francisco, CA)
- …in your career, trust **The Experts at Hiring Experts.** **Position Overview:** The Director , Global Regulatory Affairs is responsible for contributing to ... **Kelly(R) Science & Clinical** is seeking a Director of Global Rgulatory Affairs for...involves collaborating with cross-functional teams to ensure compliance with global regulatory standards and efficient management of… more
- AbbVie (Irvine, CA)
- …coordination, management of global submissions to support new registrations. As Global regulatory lead (GRL), directs and supports development of the ... policy, intelligence interpretation and strategy for medical devices to support global regulatory plans, due diligence, integration, and divestitures. + Acts… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …and tools to promote engaged, collaborative, and results-driven work environments. The Director , Global Programs ( Regulatory and Laboratory) has the ... leadership team, is responsible for developing and implementing a global growth strategy for USP's externally funded regulatory...standards, you will play a vital role in increasing global access to high- quality medicines through public… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , RA Global Regulatory Strategy, US & Canada ... a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director ),...regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier… more
- Bausch Health (Bridgewater, NJ)
- …creates it-where your skills and values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for ... labeling strategy, to deliver high quality submission labeling and artwork for complex drug products,...documents for new products. + Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory … 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...+ Ability to successfully chip in to improving the quality of internal regulatory policies, processes, programs… more
- GRAIL (Washington, DC)
- …technology, and healthcare companies. For more information, please visit grail.com . The Associate Director of Global Regulatory Affairs & Safety serves as a ... needed, on IVD product registrations and audits. Supports US regulatory team and partners with Quality , and...Supports US regulatory team and partners with Quality , and relevant cross-functional stakeholders to support UKRP audits,… more
- Edgewell Personal Care (Allendale, NJ)
- …Edgewell's values and behaviors. **Accountabilities** + Responsible for leading Edgewell's Global Regulatory organization. + Demonstrate strong business acumen, ... knowledge of Canadian Registration Processes and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and pharmacovigilance. + Proven… more
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