- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Global Regulatory Lead , GI & Inflammation where you ... project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. +...lead all submission types. + Accountable for building global regulatory strategies as defined within the… more
- BeiGene (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... on Health Authority interactions. + Uses extensive knowledge of global regulatory requirements and the ability to...a global strategy and can develop and lead execution of holistic regulatory strategy while… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, is ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- Novo Nordisk (Lexington, MA)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... on development strategies, and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed Team in defining and executing the … more
- Bristol Myers Squibb (Madison, NJ)
- …Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead regulatory dossier ... personal lives. Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products… more
- AbbVie (Irvine, CA)
- …pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, is ... + Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers. + May lead the Labeling Regulatory Strategy… more
- Lilly (Indianapolis, IN)
- …the Senior Director /Executive Director , Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative ... acceleration strategies. Identify and effectively communicate regulatory risks. + Lead Global Regulatory Team in the development of RSD(s) for assigned… more
- AbbVie (North Chicago, IL)
- …driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director ), in the development & execution of the ... Set cont'd: Proven skill at implementing successful US and Canada regulatory strategies; global regulatory experience is a plus. Additional Information… more
- J&J Family of Companies (Titusville, NJ)
- …& Johnson Innovative Medicine is recruiting for Associate Director , North America Regulatory Lead in Global Regulatory Affairs, supporting programs ... Associate Director , North America Regulatory Lead...strategy through participation in product-related teams. + Provides regional regulatory input to the Global Regulatory… more
- AbbVie (Irvine, CA)
- …within Global Regulatory Aesthetics Pharma and supports the Global Regulatory Lead (GRL, Director ), in the development and execution of the ... Set cont'd: Proven skill at implementing successful US and Canada regulatory strategies; global regulatory experience is a plus. Additional Information… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, ... develop and lead global strategies to maximize global ...reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types… more
- Takeda Pharmaceuticals (Columbus, OH)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- Takeda Pharmaceuticals (Lexington, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Affairs CMC where you will develop and ... CMC team, you will report to a Senior Director and work with stakeholders across the business. **How...for projects/products within respective modalities. + Support and/ or lead assigned global regulatory submissions… more
- Danaher Corporation (Raleigh, NC)
- …to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be responsible for developing and ... support. In this role, you will have the opportunity to: + Lead regulatory submissions, including pre-market applications, product registrations, post-approval… more
- J&J Family of Companies (Titusville, NJ)
- Director , Global Regulatory Leader (GRL) (1 of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , ... more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead...exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent… more
- Gilead Sciences, Inc. (Foster City, CA)
- …level as a global lead that ensures "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining ... in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is...Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation… more
- S&P Global (New York, NY)
- …exchange of regulatory data and documentation. The team collaborates with global regulatory bodies, including ISDA, to support protocols for Dodd-Frank, ... **Grade Level (for internal use):** 13 **_The_** **_Role:_** **_Regional Commercial Director - Regulatory Compliance_** **The Team:** This commercial position… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …interacts with other therapeutic area leaders and joint Alliance partners. **Responsibilities** + Lead a multidisciplinary Global Regulatory Team (GRT) to ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role + 7 or More… 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...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more