- 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 (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
- 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 (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...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 (North Wales, PA)
- …including the related SOPs and Execution resources. The incumbent is accountable to Sr. Director of Business Process and Systems with input from VP, CSRM as needed, ... necessary changes to any aspect of assigned process and lead integration of SOP owner activities to ensure a...functional areas and process governance committees. Works with Sr. Director for Business Process and Systems, CSRM to develop… 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