- AbbVie (North Chicago, IL)
- …Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for developing and implementing ... for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands...strategy for assigned products. + Leads preparation of global regulatory product strategies for assigned products.… 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 ... compliance. + You will lead the development and implementation of cutting-edge global strategic regulatory strategies. Your role will involve assessing … more
- Arvinas (New Haven, CT)
- …say . For more information, please visit www.arvinas.com . **Position Summary** The Executive Director , Global Regulatory Strategy is responsible for ... submission planning, labeling, advertising, and promotions. + Ensures that the global regulatory strategy for assigned products are consistent with the… more
- Organon & Co. (Jersey City, NJ)
- …products and portfolio. + Guide and coach GRLs in creating and implementing global regulatory strategy for registration, maintenance and market expansion ... Position** The successful candidate will lead a group of Global Regulatory Leads (GRLs), who are responsible...values and priorities. + Deep competency in developing optimal regulatory strategy globally and understanding of … more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , RA Global Regulatory Strategy , US & Canada is responsible for the ... a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director ),...Director ), in the development & execution of the regulatory strategy . Area of responsibility has significant… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Pleasanton, CA, USA * Princeton, NJ, USA Req #374 Friday, June 28, 2024 Looking for a chance to make a ... to lead one or two high priority late-phase clinical development programs as Global Regulatory Lead (GRL), responsible for leading regulatory sub-team… more
- Amgen (Washington, DC)
- …Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and ... can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader...and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy + Clearly… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and plan ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- BeiGene (Emeryville, CA)
- …implementing regulatory strategies. Can develop and lead execution of global regulatory strategy while considering risk/opportunity, timeline, resources. ... **General Description** + The Senior Director , Global Regulatory Lead...global project teams to plan, evaluate and recommend regulatory strategy . Externally, the individual may interface… more
- BeiGene (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... to the global project teams to plan, evaluate and recommend regulatory strategy . Externally, the individual will interface with business partners regarding… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional ... and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs, Precision...global regulatory guidance. You will provide regulatory strategy and support, ensuring communication of… more
- Pfizer (San Diego County, CA)
- …of medicines for patients. **POSITION SUMMARY** Reporting to the Head of Portfolio Strategy and Scientific Operations, you will be responsible for all Oncology ... regulatory submissions (eg, IND, CTA, BLA, NDA, PIP, Annual...Leaders and the Research Project Teams to develop IND strategy for the non-clinical pharmacology sections during Lead Development… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Bristol Myers Squibb (Princeton, NJ)
- …Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy within a development ... + Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process.… more
- AbbVie (Irvine, CA)
- …knowledge of medical device regulations, and desired experience in the CE Marking process, global regulatory strategy , and regulatory submission process. ... to support renewals. Directs and supports development of the regulatory strategy related to MPS activities for...(eg, Medical Device Regulation) for medical devices to support global regulatory plans, due diligence, integrations, and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. ... into a global strategy . + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies. + Serve as… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , Global Category Strategy Partner (GCSP)- Media Category ... is responsible for development of a robust global category strategy aligned to achieving dynamic...Partners, as well as International SS&P teams + Brand, Regulatory and Contract Law teams + Finance teams +… more
- Novo Nordisk (Princeton, NJ)
- …the Global Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and high-quality ... across multiple functional areas. Relationships You will report to the Senior Director , Global Regulatory Portfolio Lead. Essential Functions + Serve as a… more
- Takeda Pharmaceuticals (Columbus, OH)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...approvals. Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more