- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Lead , GI & Inflammation where ... you will define, develop, and lead global strategies to maximize global regulatory...project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. +… 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
- Novo Nordisk (Plainsboro, NJ)
- …multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions + Serve as a ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies… 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 (Florham Park, NJ)
- …Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead in Global Regulatory Strategy ... is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for...may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST).… 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
- Merck (Rahway, NJ)
- …and obtain shortest time to approval by regulatory agencies. + Functions as global regulatory lead assigned to programs where the compound is ... **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory...submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product… 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
- Merck (North Wales, PA)
- **Job Description** **Principal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director /Senior ... their assigned projects. **Position Description** The Principal Scientist / Director responsibilities include but are not limited to: +...+ Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or… more
- Takeda Pharmaceuticals (Washington, DC)
- …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
- Danaher Corporation (Chicago, IL)
- …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 (Trenton, NJ)
- Director , Global Regulatory Leader (GRL) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global ... 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
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , Global Regulatory Affairs in Cambridge, MA with the ... the immunology and inflammation therapeutic franchise, serve as the Global and US Regulatory Strategic Lead...Advice; Lead the development of high level global regulatory supplemental biologic application sBLA strategy… 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)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory guidance on Design Controls to product teams in line with global regulatory strategies + Develops strategies, tools and trainings to develop the ... regulatory filings through clinical development and commercial product lifecycle + Lead regulatory strategy, briefing book authoring and meetings with … more
- BeiGene (Emeryville, CA)
- **General** **Description** _:_ The Executive Director , Hematology North America Lead will be responsible for managing a team of NA leaders within the Hematology ... coordination with key internal stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of at least 2 strategist) who… more