- Novo Nordisk (Plainsboro, NJ)
- …multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions + Serve as a ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies… 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 (Trenton, 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
- Merck (North Wales, PA)
- … Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. ... business process management and continuous improvement. + Establish and lead assigned domain Global Process Control Boards...+ Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that… more
- 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
- 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....for the generation and execution of country specific CMC regulatory strategies + Lead CMC regulatory… 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
- J&J Family of Companies (Trenton, NJ)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory Medical ... potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a...plan, assessment aid) documents is preferred. + Knowledge of global regulations, regulatory timelines, guidelines, and … 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
- J&J Family of Companies (Trenton, 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...Policy & Intelligence Research Coordinator will be a key leader in the Policy team, helping the group deliver… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and… 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
- 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
- Merck (West Point, PA)
- …creative conflict resolution and problem-solving skills. + Strong knowledge of global regulatory guidelines and cGMP principles. + Demonstrated experience ... the process, analytical and facility readiness. + Manage and lead collaboration for TT related regulatory authoring...during TT. + Required to comply with our Company Global and regulatory requirements and execute current… more
- J&J Family of Companies (Horsham, PA)
- Associate Director , Global Commercial Insights and Analytics, Autoantibody (Horsham, PA) - 2406206641W **Description** Johnson & Johnson is seeking a Associate ... Director , Global Commercial Insights and Analytics, Autoantibody...and communicating cross-functionally with competitive intelligence, finance, medical affairs, regulatory and other key functions + Present insights and… more
- Merck (North Wales, PA)
- **Job Description** We are currently recruiting for an **Associate Director Global Oncology Marketing Hematology** for a non-covalent inhibitor in Leukemia and ... commercial input on such activities as:** + Target product profile development, global regulatory filing strategy, launch readiness reviews, organized customer… more
- Bristol Myers Squibb (Princeton, NJ)
- …to meet regulatory , quality, medical, and access goals + Serves as a matrix leader to lead , develop, motivate and achieve results through teams, and is the ... . **Position Summary** + CDLs are matrix leaders and managers who lead , develop, motivate and achieve results through teams; demonstrate a commitment to… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Associate Director , TA (Therapeutic Area) Analysis Standards Leader is accountable ... TA, aligning cross-functionally and driving end to end standards. Associate Director , TA Analysis Standards Leader , independently leads improvement initiatives… more