- Takeda Pharmaceuticals (Columbus, OH)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Project Management and Strategic ... Regulatory Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management and Strategic Planning, you will… more
- AbbVie (North Chicago, IL)
- …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 (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
- 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
- Novo Nordisk (Princeton, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director , Global Regulatory Portfolio Lead. Essential Functions + ... The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work...Serve as a member of the Global Project Team (GPT) utilizing precedent and… 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
- Merck (Rahway, NJ)
- … submissions, as appropriate, and corresponding therapeutic dossiers. + Interacting with global regulatory authorities and diagnostic partners to determine best ... will be responsible for: + Providing critical strategic and tactical CDx/IVD regulatory guidance that positively influences project planning and decision making.… 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
- 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
- Bristol Myers Squibb (Madison, NJ)
- …and company objectives. + Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead ... personal lives. Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products… 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
- S&P Global (New York, NY)
- **About the Role:** **Grade Level (for internal use):** 12 ** Director , Global Sanctions & Financial Crimes Compliance Program Advisor** **About the Role:** ... **Responsibilities and Impact:** **The Impact:** + The Director , Global Sanctions & Financial Crimes Compliance...management efforts. + Maintain a current awareness of the regulatory environment and emerging Global Financial Crimes… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …external contractors (eg, CRO teams and vendors); participates as a key member of Global Regulatory Project Teams; and represents Regulatory Affairs ... and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Early Development),...+ Ensures the effectiveness of execution and output for Global Regulatory Project Teams. +… 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
- Pfizer (Collegeville, PA)
- We have an exciting opportunity for a Director to join our vaccines Global Regulatory Science team as a US Regional Regulatory Strategist (RRS). This is ... (ie regional EM or US lead and/or Global Regulatory Lead for other programs), Project (s) assigned can be in development and/or at post-authorization stage *… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …ensure compliance with regulations and guidelines. + Leads as a key member of Global Regulatory Project Teams. + Leads multidisciplinary team responding to ... hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ..., Regulatory Affairs (Early Development) provides strategic global regulatory guidance to cross-functional project… 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