- Teva Pharmaceuticals (West Chester, PA)
- Director , Regulatory Affairs - Dossier Project Manager Date: Jun 20, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... Dossier Project Manager, a key member of Global Regulatory Affairs , will be responsible to develop...regulatory project plans for major global dossiers. The Director that fills this highly visible role will work… more
- Boehringer Ingelheim (St. Joseph, MO)
- …as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety &...Responsible for the safety and efficacy part of the dossier for new veterinary products as well as life-cycle… more
- Sanofi Group (Cambridge, MA)
- … positions and regulatory dossier templates + Act as the Regulatory Affairs -Devices lead on assigned project teams (early phase, late stage and marketed ... **Job Title:** Global Regulatory Affairs Device Head, Specialty Care...Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or Morristown, NJ **About… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... science or health related field + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product/ dossier management… more
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director of Regulatory Affairs - Soft Tissue Fillers ... regulatory interactions with R&D, Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory policy, intelligence… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Director of Regulatory Affairs coordinates and oversees regulatory ... industry and regulatory experience + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle + Knowledge of… more
- Bausch Health (Bridgewater, NJ)
- …CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry ... skills and values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy, to… more
- Takeda Pharmaceuticals (Lexington, MA)
- …regulatory to guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established ... as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA… more
- System One (Lakewood, CO)
- Job Title: Director , Global Market Access and Government Affairs Location: Remote w/travel Comp: 230K +/- depending on experience Leading Medical Device Company ... is hiring a Director - Patient Access and Government Affairs ...asset. + Experience with Health Economics models and clinical-economic dossier development. + Knowledge of blood, plasma, or cell… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …and demand integrity and respect in all we do, create and deliver. The Senior Director , Medical Affairs supports the Medical Affairs department in the ... national origin, protected veteran status, disability or any other legally protected status. \#ITCI Sr. Director , Medical Affairs Base Salary range $210K - $270K more
- Gilead Sciences, Inc. (Foster City, CA)
- …with global and US TA MA, Managed Markets, Value and Access, Commercial and Government Affairs , develop Medical Affairs strategies and POAs to ensure that PAQ is ... the appropriate avenues for early scientific engagement and AMCP and preapproval dossier development. + In partnership with the FD's, coordinate efforts and provide… more
- Cardinal Health (Phoenix, AZ)
- …capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + Nonclinical ... success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory ...+ Clinical Development and Research + Medical Writing + Regulatory Publishing + Dossier Services + Submission… more
- BeOne Medicines (San Mateo, CA)
- …one or more Global Product Teams (GPTs). + Collaborate with R&D, Commercial, Medical Affairs , and Regulatory Affairs to ensure access-related insights and ... Description:** The position will report directly to the Executive Director (ED), Global Value, Access & Pricing (GVAP) Lead,...and communication. + Collaborate closely with Pricing, HEOR, Medical Affairs , Commercial, and Regulatory Affairs … more
- Abbott (Princeton, NJ)
- …defining the innovation roadmap to fill gaps + Partner with R&D, Clinical Affairs , Regulatory , Quality and Operations to ensure product development resources are ... of Care and the i-STAT System, please visit https://www.pointofcare.abbott . **Sr. Director , Global Strategic Marketing: A Unique Leadership Opportunity** As the Sr.… more
- Sanofi Group (Morristown, NJ)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... **Job Title:** Senior Clinical Research Director , Ophthalmology **Location** : Cambridge, MA Morristown, NJ...the project in collaboration with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver… more
- Bristol Myers Squibb (Princeton, NJ)
- …team and closely collaborate with Clinical Operations, Clinical Development, Biometrics, and Regulatory Affairs . + Contribute to the design and execution of ... team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Senior Director - Clinical Pharmacology will be a key member of the development team,… more
- AbbVie (San Francisco, CA)
- …with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director , or Director ), in the ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- Medexus Pharma (AL)
- …Alabama, South Carolina, North Carolina** **Position Overview** Reporting directly to the Director , Field Access- The Field Access Manager (FAM) drives market access ... target account plans to maximize treosulfan uptake, collaborating with Marketing, Medical Affairs , and Market Access to ensure alignment with company objectives. +… more