- Bristol Myers Squibb (Princeton, 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
- J&J Family of Companies (Titusville, NJ)
- …& Johnson Innovative Medicine is recruiting for Associate Director , North America Regulatory Lead in Global Regulatory Affairs, supporting programs ... Associate Director , North America Regulatory Lead...strategy through participation in product-related teams. + Provides regional regulatory input to the Global Regulatory… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …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
- J&J Family of Companies (Titusville, NJ)
- Director , Global Regulatory Leader (GRL) (1 of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , ... 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 (Trenton, NJ)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Bristol Myers Squibb (Princeton, NJ)
- …teams on practical aspects of global change management. **Responsibilities** Represent regulatory CMC on and/or lead matrix teams for biologics pipeline ... of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with...to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Summary:** The Director of Pricing and Market Access Strategy Lead will be responsible for the overall Global Market Access (GMAx) ... medical, regulatory , clinical, advocacy, policy, business Insights & analytics global leads), and with the relevant individual market stakeholders across the… more
- Ascendis Pharma (Princeton, NJ)
- …US & Americas labelling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy . ... for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will...for the United States and the Americas and supporting global needs as required. The RA Associate Director… more
- Taiho Oncology (Princeton, NJ)
- …Summary: Under the leadership of Regulatory Affairs the incumbent manages global regulatory operational activities (except Asia) for all Taiho Oncology, ... Associate Director , Regulatory Affairs Operations Pleasanton, CA,...contract review and negotiation. + Strong working knowledge of global regulatory requirements and submission processes. +… more
- J&J Family of Companies (Titusville, NJ)
- …and SharePoint **Preferred:** * Experience at Health Authority * Understanding of the global regulatory environment, including in US, EU, and AP The anticipated ... Director , Regulatory Policy and Intelligence Research...and delivers results. **Primary responsibilities:** * **Scientific Research Support:** Lead , provide, and coordinate research support for GRA and… more
- Lilly (Philadelphia, PA)
- …people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global CMC regulatory activities for ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...for the generation and execution of country specific CMC regulatory strategies + Lead CMC regulatory… more
- Bristol Myers Squibb (Princeton, NJ)
- …the regulatory landscape, assessing regulatory risk, and developing global filing strategies. + Co- lead marketing application submission teams for ... more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of… more
- Sanofi Group (Bridgewater, NJ)
- …gastrointestinal diseases. **Main Responsibilities:** The Early Pipeline Gastroenterology Associate Medical Director reports to the Global Medical Head of ... curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to...direction of the Global Respiratory and Gastroenterology Global Medical Lead This role will closely… more
- Sanofi Group (Bridgewater, NJ)
- …for chronic dermatologic, respiratory, and gastrointestinal diseases. **Main responsibilities:** + The Global Medical Director of Rheumatology, reports to the ... function serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to...works under the direction of the Dermatology and Rheumatology Global Medical Lead . + This role will… more
- Bristol Myers Squibb (Princeton, NJ)
- … , this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory , IT, Audit, Finance and HR to build and ... integrate one global compliance program into...their decisions. + Under the direction of the Senior Director , US and Above Market Medical and Market Access C&E… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Position Summary** + CDLs are matrix leaders and managers who lead , develop, motivate and achieve results through teams; demonstrate a commitment to ... with target label indications and are designed to meet regulatory , quality, medical, and access goals + Serves as...access goals + Serves as a matrix leader to lead , develop, motivate and achieve results through teams, and… more
- Pfizer (Collegeville, PA)
- … regulatory requirements of different sites and countries. + Ability to lead cross-line global initiatives or root cause analysis for quality related ... within the Pfizer Oncology clinical portfolio. + With this focus, the Asset Quality Lead (AQL) role brings deep knowledge of Level One quality issues and risk areas… more
- Bristol Myers Squibb (Princeton, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary** Reporting to the Sr Director WWMO, Portfolio Strategy Lead To oversee and drive Pan ... Leads, Global Congress Excellence team and the Professional Societies Lead to deliver Oncology Congress Strategy and narrative. **Qualifications & Experience** +… more
- Bristol Myers Squibb (Princeton, NJ)
- …support implementation of corrective actions to achieve performance targets. People Management: o Lead , mentor, and develop a high-performing global O2C team. o ... allocation and succession planning to ensure team effectiveness. Project Management: o Lead and manage global O2C projects, ensuring timely and successful… more
- Sanofi Group (Bridgewater, NJ)
- **Position Title: - Director , Portfolio Marketing Strategy Lead - Portfolio Marketing** Location: Bridgewater and Morristown + 50% remote working and 10% of ... for diversity in 2021 by Diversity Inc. Sanofi US is part of a leading global healthcare company that is dedicated to improving health and driving back disease by… more