- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and ... product development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical… more
- Ralliant (Raleigh, NC)
- …a key legal advisor and strategic partner to the **_Assistant General Counsel, Global Regulatory and Government Affairs_** providing expert legal counsel and ... leadership across Ralliant's global regulatory and government affairs portfolio. The...on business operations and advising internal stakeholders accordingly. + Lead or support global initiatives and programs… more
- Insmed Incorporated (San Diego, CA)
- … Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product ... Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where they...point of contact for interactions with FDA and other Global health authoritiesAssist/ Lead communications with FDA and… more
- Insmed Incorporated (NJ)
- …understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of... strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation… more
- BeOne Medicines (Emeryville, CA)
- …analytics, and continuous improvement initiatives, helping to strengthen BeOne's global regulatory compliance framework and ensuring proactive identification ... Framework & Readiness** + Support the implementation and strengthening of BeOne's Global Regulatory Compliance Framework. + Ensure regulatory programs… more
- Parexel (Tallahassee, FL)
- …excellence and innovation in post-marketing activities. Key Responsibilities - Develop and lead global post-approval regulatory strategies for assigned ... **Join Parexel as a Post-Approval Regulatory Strategy Lead !** Are you a...with a passion for navigating the complex world of global regulatory affairs? Do you thrive in… more
- Organon & Co. (Plymouth Meeting, PA)
- …through the product lifecycle.? + Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of ... guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for...CMC changes, identification of global regulatory requirements and critical evaluation of… more
- CSL Behring (Waltham, MA)
- …(eg protocol, TPP, etc.) generated from PST, CDT, SMT and related delivery teams. May lead discussion at Global Regulatory Forum (GRF) or with senior ... worldwide. Could you be our next Senior Manager Regional Regulatory Lead , Vaccines? The job is in...employee. **About CSL Behring** CSL Behring (http://cslbehring.com/) is a global biotherapeutics leader driven by our promise… more
- Organon & Co. (Plymouth Meeting, PA)
- …of all regulatory milestones for?assigned?products through the product lifecycle.?? + Lead development and execution of global product and project ... strategy(ies) by ensuring robust assessment of CMC changes, identification?of? global ? regulatory requirements and critical evaluation of supporting documentation… more
- The Clorox Company (Pleasanton, CA)
- …and Cosmetic Act (FD&C Act), Modernization of Cosmetics Regulation Act (MOCRA)], global regulatory frameworks (including European Union, Canada and Asia ... care and over-the-counter (OTC) drug products. This role independently leads regulatory activities, ensuring compliance with global regulations while enabling… more
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