- Aldevron (Miami, FL)
- …Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic ... as the site's primary contact with both customers and regulatory agencies regarding quality/compliance issues and Negotiate Quality AgreementsDevelop and… more
- Cytiva (Pensacola, FL)
- …about the Danaher Business System, which makes everything possible.As the Senior Manager, Site Quality you will collaborate closely with cross functional ... certification requirements and customer expectations.This position reports to the Quality Director Filtration - Membrane Sites and leads both the Quality Control… more
- Lilly (Indianapolis, IN)
- …determined 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… 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 ... a pivotal role in shaping outcomes that matter. The Director , Global Regulatory Strategy and...+ Prepare detailed reports, briefing notes, and presentations on regulatory policy matters. + Advise senior management… more
- Lilly (San Francisco, CA)
- …determined 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… 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 ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- BeOne Medicines (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... management and advice on Health Authority interactions. + Uses extensive knowledge of global regulatory requirements and the ability to apply knowledge both… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages ... regulatory strategies for both development and commercial products. Additionally, the Senior Director is committed to fostering continuous improvement in … 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...field. * Minimum of five (5) years in leadership/ senior role at the US Food and Drug Authority.… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director Regulatory Affairs Global Regulatory Lead, ... and, if applicable, ensure direct reports follow requirements. + Ensures alignment of global regulatory strategies with Sr . Management. Under minimal… more
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