- BeiGene (San Mateo, CA)
- …Senior Director is responsible for setting the vision and mission for the Global Regulatory Operations &GRA Excellence function. The head of GRO and GRA ... corporate vision, mission, and values. As the Head of Global Regulatory Operations, the SD will lead...use of Microsoft Office Suite (Word, Excel, Power Point, Project , Visio). + Clear understanding of the role that… more
- BeiGene (Emeryville, CA)
- …and makes good decisions for the overall business. + Manages and leads an effective global regulatory project team via indirect reporting structure. + Builds ... **General Description** **_:_** + The Director , Global Regulatory Lead,...acts as an advisor/liaison to the global project teams to plan, evaluate and recommend regulatory… more
- AbbVie (Boston, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director , Global Regulatory Lead, is responsible for developing and ... 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 (San Mateo, CA)
- …and makes good decisions for the overall business. + Manages and leads an effective global regulatory project team via an indirect reporting structure. + ... **General Description** + The Senior Director , Global Regulatory Lead...acts as an advisor/liaison to the global project teams to plan, evaluate and recommend regulatory… more
- BeiGene (Emeryville, CA)
- **General** **Description** **_:_** **The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising ... on global regulatory strategies for development programs to...and acts as an advisor/liaison to senior management and project teams to plan, evaluate and recommend regulatory… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs, Precision Medicine you will ... Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional stakeholders across… more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy within a development team (DT). ... from HAs for respective regions/countries + Prepare content for regulatory strategic documentation and Regulatory Project...+ Ensure global development plans will meet global regulatory requirements by soliciting and integrating… 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 ... meetings globally. Responsible for representing GRA in the GPT ( Global Project Team) as well representing the... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT… more
- Novo Nordisk (Lexington, MA)
- …make a difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... medicines. You will lead a global regulatory team to...Essential Functions + Serve as a member of the Global Project Team (GPT) utilizing precedent and… more
- Olympus Corporation of the Americas (Westborough, MA)
- … regulatory agencies regarding compliance issues. Directs the development of global regulatory communication processes to include responses to external audits ... and directs regulatory compliance communications to ensure compliance of the Global Quality System with applicable regulatory requirements and with the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …+ As a regulatory professional, you will contribute to a holistic global strategy for assigned CRM projects. Your leadership and in-depth expertise will enable ... compliance. + You will lead the development and implementation of cutting-edge global strategic regulatory strategies. Your role will involve assessing … 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...position may serve as an ad hoc member of Global Project Team (GPT) to address labeling… more
- Novo Nordisk (Lexington, MA)
- …and frequent interaction with Project Vice Presidents and other colleagues across global R&D. The Nonclinical Project Director will lead nonclinical ... a project . About the Position As Nonclinical Project Director you will be heading nonclinical...applications, regulatory interactions, and market registration to global regulatory authorities (eg IB, pre-IND, IND/CTA… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** The ... Sr Director , CMC Regulatory Affairs for Small Molecules is responsible for managing...global portfolio of small molecule products in CMC Regulatory Affairs. This position will lead a global… more
- Taiho Oncology (Pleasanton, CA)
- …Directs and coordinate regulatory activities of external consultants in consultation with Global Executive Director or designee. + Prepare project and/or ... Director , Regulatory Affairs CMC Pleasanton, CA,...Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for… more
- Teva Pharmaceuticals (West Chester, PA)
- …making a difference, and new people to make a difference with. **The opportunity** The Director , Global Regulatory Affairs, is a strategic role that will be ... Director , Regulatory Affairs, Strategy - Innovative...innovative medicine development; working in a matrixed cross functional project team and global regulatory … more
- Teva Pharmaceuticals (West Chester, PA)
- … Regulatory Affairs you will be responsible for acting as and supporting the Global Regulatory Lead (GRL) in strategic vision and innovative scientific and ... Associate Director , Regulatory Affairs - Remote OR...regulatory leadership in defining the global regulatory strategy for biosimilar (BioS) projects.… more
- Teva Pharmaceuticals (West Chester, PA)
- …in Global Regulatory Operations management team meetings. + Leads major Global Regulatory Affairs project teams. + Develop functional SOPs as well ... Senior Director , Regulatory Affairs II Date: May...Stock Purchase Plan and Tuition Assistance. **Reports To** VP Global Regulatory Affairs **Already Working @TEVA?** If… more
- Ascendis Pharma (Palo Alto, CA)
- …strategies; identifies and proposes risk mitigation strategies; influences global project teams and sub-teams . Provides regulatory information and guidance ... The Director , Regulatory Affairs will be responsible... Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and… more
- Taiho Oncology (Pleasanton, CA)
- …to lead one or two high priority late-phase clinical development programs as Global Regulatory Lead (GRL), responsible for leading regulatory sub-team ... Sr. Director , Regulatory Affairs Strategy Pleasanton, CA,... regulatory agencies. + Strong working knowledge of global regulatory requirements and submission processes. +… more