- J&J Family of Companies (Titusville, NJ)
- …+ Represents CMC regulatory affairs in major disease area/ program /sub-function/regional area in senior internal management and governance bodies ( ... Senior Director, CMC Regulatory Affairs...regulatory processes, policies, and product/ program specific regulatory aspects to cross-department global/regional Senior Leadership… more
- Bausch Health (Bridgewater, NJ)
- …**KEY ACTIVITIES/** **RESPONSIBILITIES:** + Serve as a leadership team member for Global Regulatory Affairs + Lead and grow individuals on the Regulatory ... standards and other best practices guidelines + Identify opportunities to streamline Regulatory Affairs processes to promote operational excellence + Provide… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... product development activities/meetings + Perform research to support the development of regulatory strategy for the assigned clinical development program +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The candidate will be leading the regulatory strategies for biologic products and combination products for the product portfolio assigned. **In this role, a typical ... + Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …for the clinical research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the ... Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Global Regulatory Affairs Lead** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The Global Regulatory Affairs Lead (GRL) is ... is the single GRA point of contact for the program and represents GRA at the GPT / GBT...pharmaceutical/biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and global), in… more
- Hackensack Meridian Health (Edison, NJ)
- …transform healthcare and serve as a leader of positive change. The **Director, External Affairs ** for HMH is responsible for assisting the SVP, Chief of External ... Affairs in the development and management of External ...and measurable deliverables. + Builds an executive thought leadership program , identifying and establishing a voice for each leader,… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible ... alignment for other medium and/or high complexity products. Interface with Senior Management Cross-Functional Team (GLOC) + Coordinates the process to obtain… more
- Sanofi Group (Bridgewater, NJ)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global), in early and ... regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed. + May lead Health Authority...initiation + Ensure that regulatory messaging for regulatory submission documents is aligned with program … more
- WM (Trenton, NJ)
- …compliance, accuracy and efficacy of the information. The role Interfaces with the regulatory community and informing the WM public affairs professionals in ... Stability. Growth Opportunities. People-First Culture (https://www.wm.com/us/en/inside-wm/who-we-are) . **About the Regulatory and Compliance Manager Role** The Regulatory … more
- Novo Nordisk (Plainsboro, NJ)
- …the VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. ... with the VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …maintain a demand forecast for managed brands. Build relationships with legal, medical affairs , regulatory affairs to ensure appropriate review of marketing ... Description: The Senior Manager, Oncology Marketing is responsible for creating and implementing the brand strategy and omnichannel marketing plan for several… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... immune disorders. **Summary** Oversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical… more
- J&J Family of Companies (New Brunswick, NJ)
- Senior Director, Executive and Global Organization Communications - Innovative Medicine - 2406181361W **Description** Johnson & Johnson is currently recruiting for a ... Senior Director Executive Communications and Engagement, located in New...role with the J&J Innovative Medicine Communications and Public Affairs organization, responsible for developing and implementing an integrated… more
- Bristol Myers Squibb (Warren, NJ)
- …including CATD teams, CMC, Analytical Science and Technology (AS&T), Quality Control, Regulatory Affairs , and Project Management, to ensure alignment and ... and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Senior Principle Engineer, Assay and Data Automation, Cell Therapy** **Location:… more
- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . Position Summary : The Senior Director, Compliance and Ethics Organization - Medical and Market Access ... - a Director , two Associate Directors and one Senior Manager - who support the US and Worldwide...leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory , IT, Audit, Finance and HR to build and… more
- J&J Family of Companies (Titusville, NJ)
- Senior Manager, Health Care Compliance Officer - 2406200772W **Description** Johnson & Johnson is currently seeking a Senior Manager, Health Care Compliance ... will provide direction and oversight of the Health Care Compliance (HCC) Program across Janssen Pharmaceuticals, Inc and ensure the business integrates health care… more
- Bristol Myers Squibb (Princeton, NJ)
- …. Reporting into the Medical Value Liaison Field Director, the Senior Medical Value Liaison (MVL)/Executive MVL is a field-based role focused ... policy makers, and other decision makers and influencers. **Responsibilities** ** Senior Medical Value Liaison** + Provide comprehensive, accurate, fair, balanced,… more
- Edwards Lifesciences (Trenton, NJ)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more