- Olympus Corporation of the Americas (Center Valley, PA)
- …an entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Regulatory Affairs Operations Manager, is responsible for ... objectives. The Operations Manager will work directly with the VP of Global Regulatory Affairs Operations to ensure the smooth and efficient delivery… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... mid-size oncology company in the role of Associate Director, Regulatory Affairs Operations where you...community we serve. Position Summary: Under the leadership of Regulatory Affairs the incumbent manages global… more
- Merck (North Wales, PA)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... as appropriate, and corresponding therapeutic dossiers. + Interacting with global regulatory authorities and diagnostic partners to...devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of… more
- Merck (North Wales, PA)
- …The GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business ... various SMEs, including leading cross-functional teams, to drive process improvements, streamline operations , and achieve business objectives on a global scale.… more
- Merck (North Wales, PA)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** Our Regulatory Affairs team bring new medical... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or… more
- CSL Behring (King Of Prussia, PA)
- …manufacture and commercial launch. Interface with other disciplines including Global Regulatory Affairs , Project Management, Operations and Commercial ... is responsible for the leadership and co-ordination of all regulatory GxP inspections for the R&D teams and across...Pharmacovigilance and Safety. Responsible for the execution of the global audit program for R&D, including internal systems and… more
- Bausch Health (Bridgewater, NJ)
- …collective progress and impact. **OBJECTIVES/** **PURPOSE OF JOB:** The Senior Director of Global Regulatory Operations is responsible for directing and ... **RESPONSIBILITIES:** + Serve as a leadership team member for Global Regulatory Affairs + Lead...Affairs + Lead and grow individuals on the Regulatory Operations team + Define and implement… more
- Merck (North Wales, PA)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** Our Regulatory Affairs team bring new medical...with a growth mindset. **Position Description:** The Senior Director, Global Regulatory Lead, is responsible for development… more
- J&J Family of Companies (Titusville, NJ)
- Principal Scientist, CMC Regulatory Affairs - 2406205078W **Description** Johnson & Johnson is recruiting for a **Principal Scientist, CMC Regulatory ... potential. At Johnson & Johnson, we all belong. The Principal Scientist, CMC Regulatory Affairs provides support for the registration activities for a diverse… more
- Sanofi Group (Bridgewater, NJ)
- … Regulatory CMC strategies for development and marketed products within Global Regulatory Affairs . You'll have direct contact/liaison with FDA/EMA ... **Job title:** Manager, Regulatory Affairs CMC - Vaccine +...critical in helping our teams accelerate progress. Join our Global Regulatory Chemistry Manufacturing and Controls (CMC)… more
- Terumo Medical Corporation (Somerset, NJ)
- Regulatory Affairs Specialist Date: Aug 16, 2024 Req ID: 3445 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: Regulatory ... + Must make a proactive contribution to the overall Regulatory affairs department growth. + Participates in...Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards preferred.… more
- Organon & Co. (Plymouth Meeting, PA)
- …agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage ... **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist (Associate Director) is… more
- Integra LifeSciences (Princeton, NJ)
- …with colleagues in the Marketing, Business Development, R&D/Process Technologies Clinical Operations , Strategy, Regulatory Affairs , Market Access, and ... team. This role works closely with key stakeholders (R&D/Process Technologies, Clinical Operations , Regulatory , Commercial, and other functions) to support the… more
- J&J Family of Companies (Horsham, PA)
- …partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (eg Biostats, GCO, Regulatory Affairs , QA and QC) to ... with other GI team members in the US and Global Medical Affairs Organization, as well as...matrix clinical trial teams and external investigators/KOLs on study operations and provide program leadership and medical oversight. *… more
- Sumitomo Pharma (Trenton, NJ)
- …Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and ... with the US Field Medical team, Medical Communications & Operations , Japan medical affairs colleagues, RWE (Real...global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada… more
- Bausch + Lomb (Trenton, NJ)
- …**Contacts (Internal And** **External)** + **Internal:** US Medical Affairs , Regulatory Affairs , Clinical Operations , Research & Development/Life Cycle ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...eye health in the future. **Position** **Summary** The Medical Affairs Director provides support to the Medical Affairs… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Serves as a principal assistant to the Global Head of Legal - Regulatory , Quality, Medical & Scientific Affairs . Responsible for management of the delivery ... operations and functional areas for Medical & Scientific Affairs (MSA) and Quality Assurance & Regulatory ...by the Global Head of Legal - Regulatory , Quality, Medical & Scientific Affairs , including… more
- Sanofi Group (Bridgewater, NJ)
- …clinical, and market access on therapeutic solutions to support patients' needs.Within the Global Medical Affairs Immunology team, we are proud to support ... experience highly preferred + Experience in pipeline, clinical development and/or medical affairs on a global or regional level (commercial experience a… 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 ... experience highly preferred. + Experience in pipeline, clinical development and/or medical affairs on a global or regional level (commercial experience a… 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 ... + Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory ...Regulatory Team (GRT) + Liaises with US Labeling Operations , EU Labeling Operations , Labeling Devices Lead… more