- AmerisourceBergen Drug Corporation (Conshohocken, PA)
- …400+ pharmaceutical manufacturing partners, enterprise IT, category management, regulatory assurance, and other various cross-functional teamsEstablish and manage ... cross-business labeling issue resolution committeeManage a team of associates including senior Label Analysts, senior Data Analysts, Data Analysts, contractors,… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation ... where you will define, develop and lead global strategies to maximize global ...their regional counterparts. **How you will contribute:** + The Senior Director will be responsible for complex… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Purpose: The purpose of the Senior Director /Executive 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
- 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 ... updates, by ensuring accuracy, completeness, and timeliness. + Monitor and interpret global regulatory requirements and trends, provide strategic guidance to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …(GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, ... area leaders and joint Alliance partners. **Responsibilities** + Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory … more
- Novo Nordisk (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions + Serve ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines.… more
- Teva Pharmaceuticals (Ulm, AR)
- …a company pension scheme **Funktion** Research & Development **Reports To** Senior Director , Head of Global Regulatory Medical Writing **Contact** Judith ... Director (m/f/d) Therapy Area Head, Global Regulatory Medical Writing Date: Sep...your achievements are valued accordingly (eg through recognition and Senior -Leaders-Programs, as well as various company events) + we… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is ... professionals, who work with a specific product in Gilead's global portfolio of biological products in CMC Regulatory...(Biologics) submissions, and "right to operate" by maintaining the global licensures. In addition, the Sr Director … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be ... into practical, workable plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** ... **RESPONSIBILITIES** The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of scientists, who collaborate with product… more
- AbbVie (South San Francisco, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- BeiGene (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
- 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
- Global Foundries (Washington, DC)
- …some of the world's most inspired technology companies. With a global manufacturing footprint spanning three continents, GlobalFoundries makes possible the ... or as a manager: + Ensure organizational awareness of government legislation and/or regulatory issues that affect the organization and respond to same. + Represent… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory guidance on Human Factors to product teams in line with global regulatory strategies + Develops strategies, tools and trainings to develop the ... with line management + Supports and/ or leads assigned device-related aspects of global regulatory submissions (eg, Core Dossiers, INDs, CTAs, BLAs, MAAs,… more
- Amicus Therapeutics (Marlow, OK)
- Senior Director , Global Quality...all parts of the business to ensure compliance with global quality and regulatory requirements and drive ... # of openings 1 Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1322) Job Brief Senior Director - Global Quality… more
- BeiGene (Emeryville, CA)
- …to define and implement the sourcing vision and global strategy Regulatory and ensure vendor management/oversight capability. Senior leaders will include key ... of Staff/Strategic Operations Lead will report directly to the SVP of Global Regulatory Affairs. The incumbent will + Be accountable for the business operations… more
- AbbVie (Florham Park, NJ)
- …needs. Presents process, strategy and product labeling (CCDS, US/EU labeling documents) at Senior level meetings ( Global Regulatory Forum (GRF), Executive ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs, Strategic Labeling is responsible for setting… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …providing oversight for device and drug-device combination work outsourced by the Global Regulatory Affairs CMC Device and Drug-Device Combinations to external ... regulatory strategy and/or operational expertise and lessons learned to shape global regulatory best practices, drive internal consistency and influence… more
