- Merck (Upper Gwynedd, PA)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… more
- J&J Family of Companies (Titusville, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader located in New Jersey or Pennsylvania. At Johnson & ... exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on… more
- Merck (North Wales, PA)
- …Description** We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset ... and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical...external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine + Works… more
- Merck (North Wales, PA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... release from our company to external agencies and investigators. + Represents Global Regulatory Affairs (GR) within internal committees to provide … more
- Merck (North Wales, PA)
- …standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... **Job Description** Reports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Integra LifeSciences (Princeton, NJ)
- …in the Marketing, Business Development, R&D/Process Technologies Clinical Operations, Strategy, Regulatory Affairs , Market Access, and other key functions, to ... and making headway to help improve outcomes. The Medical Director for the Surgical Reconstruction (SR) Franchise will be...regulations in the medical device industry. + Experience in global Medical Affairs or similar function and… more
- Merck (North Wales, PA)
- …medicines that help people with cancer across the globe. The Regional Associate Director of Medical Affairs - Gastrointestinal Cancer (RADMA) position is a ... with the Upper GI and Lower GI US Regional Director of Medical Affairs (RDMAs) and partner...to provide region-specific strategic input into the development of global medical affairs plans + Collaborates across… more
- Takeda Pharmaceuticals (Trenton, NJ)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Merck (North Wales, PA)
- …for projects of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... **Job Description** Under general supervision of an Executive Director /Senior Director , the Principal Scientist /...Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to… more
- Merck (North Wales, PA)
- …position operates under the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance ... + Provide financial planning, forecasting and analytical support to ourResearch&DevelopmentDivision, Global Regulatory Affairs & Clinical Safety (GRACS),… more
- Merck (Trenton, NJ)
- …up with the latest regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and ensure submission readiness in all ... **Job Description** The Executive Director , Device Quality & Regulatory will...emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as… more
- Sanofi Group (Bridgewater, NJ)
- …of patients around the world. **Medical Director ** **- Global Medical Evidence Generation** supports disease registries, post- regulatory authorization ... **Job Title:** Medical Director - Global Medical Evidence Generation...with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong… more
- Bristol Myers Squibb (Princeton, NJ)
- …Lead , 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...Include : + Conduct risk assessments specific to medical affairs and clinical trial /research activities, utilizing a combination… more
- Merck (North Wales, PA)
- **Job Description** We are currently recruiting for a ** Director Global Oncology Marketing** for Lung cancer for our Company's oncology business. The Global ... in Rahway, NJ and will report to the Executive Director , Global Marketing for NSCLC. The position...complex set of stakeholders, including research and development, medical affairs , regulatory affairs , market analytics,… more
- Sanofi Group (Bridgewater, NJ)
- …and market access on therapeutic solutions to support patients' needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's ... for chronic dermatologic, respiratory, and gastrointestinal diseases. **Main responsibilities:** + The Global Medical Director of Rheumatology, reports to the … more
- Integra LifeSciences (Princeton, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The Director , Global Regulatory Labeling is responsible for overseeing the ... regulatory affairs and quality assurance and working knowledge of global regulatory labeling requirements in key markets/geographies. + Ability to… more
- Sanofi Group (Bridgewater, NJ)
- ** Global Medical Director , Early Pipeline Respiratory, Global Medical Immunology** **About Sanofi** At Sanofi, we are committed to the growth of our people, ... clinical care. We curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to develop… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- ThermoFisher Scientific (Bridgewater, NJ)
- …highly motivated and experienced individual to join our team as Global Medical Director , Allergy on the Medical and Scientific Affairs (MSA) team. In this ... quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at...different departments, such as marketing, sales, manufacturing, quality and regulatory affairs . You will also collaborate with… more