- Parexel (Trenton, NJ)
- …strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and love ... Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role,...interactions with health authorities. - Deep understanding of global regulatory frameworks (ICH, FDA , EMA, etc.) and… more
- BeOne Medicines (Emeryville, CA)
- …advanced degree preferred + Preferred candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior experience with both ... **General Description:** The Director, Regulatory Affairs will be responsible for...are met. Externally, the individual will interface with outside regulatory agencies and more specifically, the FDA ,… more
- Parexel (Trenton, NJ)
- …of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs , or ... go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs , Technical Operations, Safety, and Commercial. You'll help… more
- BeOne Medicines (Emeryville, CA)
- …medical affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, ... and train on the Food, Drug and Cosmetic Act, FDA guidance documents, industry codes and standards (eg, PhRMA,...discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related… more
- Teleflex (Minneapolis, MN)
- Clinical Affairs Manager, Interventional Access (REMOTE) **Date:** Nov 9, 2025 **Location:** Minneapolis, MN, US **Company:** Teleflex **Expected Travel** : Up ... **Position Summary** **TRAVEL REQUIRED: 50% (Domestic and International; overnight required)** The Clinical Affairs Manager will provide clinical expertise,… more
- Olympus Corporation of the Americas (Washington, DC)
- …to internal stakeholders and government audiences. + Collaborate cross-functionally with Regulatory , Legal, Clinical , Commercial, and Market Access teams to ... + Serve as the primary representative to policymakers, agencies ( FDA , CMS, HHS), legislative staff, and state health authorities....preferred. + Minimum 15+ years of experience in government affairs , public policy, or regulatory strategy, with… more
- GRAIL (Washington, DC)
- …and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome ... information, please visit grail.com . GRAIL is seeking a seasoned federal government affairs leader to shape and execute our engagement strategy in Washington, DC… more
- ITG Brands (Greensboro, NC)
- …relevant scientific discipline and possess deep expertise in regulatory strategy, toxicology, clinical studies, and FDA engagement. - WHAT YOU WILL DO + Lead ... submission of Premarket Tobacco Product Applications (PMTAs) and other regulatory filings to the FDA Center for...or related field. + 7+ years of experience in regulatory affairs or scientific leadership, preferably in… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- BeOne Medicines (Emeryville, CA)
- …feasibility, site selection, and regulatory readiness. + Partner with Clinical Operations, Feasibility, and Medical Affairs colleagues to integrate patient ... models that strengthen representative patient enrollment. This role collaborates across Clinical Operations, Regulatory , Development, and corporate functions to… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …and Scientific Affairs group, an integral delivery unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable ... clinical trials. This role ensures the integrity, accuracy, and completeness of clinical trial data in compliance with regulatory standards, SOPs, and Good … more
- BeOne Medicines (San Mateo, CA)
- …role provides compliance oversight and guidance across Regulatory Operations, Regulatory Affairs , Quality, Safety/Pharmacovigilance, Clinical , CMC, and ... or biotech industry required. + Strong knowledge of global regulatory requirements and standards, including FDA , EMA, MHRA, Health Canada, PMDA, 21 CFR Part 11,… more
- Terumo Medical Corporation (Somerset, NJ)
- …ID: 5279 Location: Somerset, NJ, US Company: Terumo Medical Corporation Department: Clinical Affairs Terumo Medical Corporation (TMC) develops, manufactures, and ... / 14971, 21 CFR 50/56/812, and ICH-GCP and applicable regulatory requirements, while driving continuous improvement in clinical.../ 13485 / 14971, 21 CFR 50/56/812, ICH-GCP, and FDA regulations - Strong auditing and risk management skills.… more
- Terumo Medical Corporation (Somerset, NJ)
- …and scientific support for the organization that includes Medical Affairs , Clinical Operations, Sales, Marketing, Regulatory Affairs , to ensure maximum ... and external stakeholders. + Build relationships and demonstrate the clinical outcome and benefits of company products to Key...+ Regulatory activities partnership: + Work with regulatory affairs to ensure that all written… more
- Endo International (St. Louis, MO)
- …of 15 years of pharmacuetical industry experience in a Quality Assurance and/or Regulatory Affairs function including experience in manufacturing and control of ... + Minimum 5 years managerial experience in a pharmaceutial quality/ regulatory affairs environment. _Preferred Skills/Qualifications:_ + Previous experience… more
- Terumo Medical Corporation (Somerset, NJ)
- …cross-functionally, will collaborate with internal stakeholders, to include Clinical Affairs , Professional & Clinical Education, Regulatory Affairs ... Marketing, Sales as well as external stakeholders, to include FDA , NB, PMDA, KOL, HCP, IRB and publishers. The...reports, documents and scientific presentations in cooperation with the Clinical , Medical, & Regulatory Affairs … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …areas. + Execute global internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates audit corrective actions ... + Coordinates and leads audit activities with all global regulatory agencies (eg FDA , Notified Bodies, PMDA,...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Caris Life Sciences (Tempe, AZ)
- …clinical performance studies. The Global Companion Diagnostics Specialist will collaborate with Clinical Research, QA, Regulatory Affairs and other study ... + Contribute to and/or lead process improvements. + Socialize regulatory requirements and standards (eg, FDA , ICH...IVD clinical studies. + Understanding of Good Clinical Practices (GCP) and other relevant regulatory … more
- Cordis (Irvine, CA)
- …Accountabilities** + Collaborate with cross-functional teams, including product management, regulatory affairs , quality assurance, and manufacturing, to define ... + Knowledge of medical device design principles, human factors engineering, and regulatory requirements (ISO 13485, FDA guidelines, etc.). + Proficiency in… more
- BeOne Medicines (Emeryville, CA)
- …leading or working with centralized teams for Statistical Programming + Experience in FDA /EMEA/CFDA trial and regulatory submissions + Experience with the drug ... collaborate with cross-functional teams, including biostatistics, epidemiology, and medical affairs to design, implement, and deliver high-quality analytic datasets,… more
