- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... other technical functions and will act as the primary regulatory contact for the US FDA . The...and experience . Lead development and execution of global regulatory strategies for clinical , pre- clinical ,… more
- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Regulatory Operations and works cross-functionally with internal departments on Regulatory Affairs related issues. Essential Functions With direction from ... About the Department The Clinical , Medical and Regulatory (CMR) department...organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Insmed Incorporated (NJ)
- …timelines, submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs , CMC, Clinical , Quality) to facilitate ... the future of science, we're in. Are you?About the Role:We're looking for an Associate, Regulatory Affairs Operations on the Regulatory Affairs team to… more
- Novo Nordisk Inc. (Seattle, WA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …to FDA guidelines for 505(b)(2) applications and other regulatory standards.Addressing medical/ clinical queries from health authorities. Leadership and ... target product profile (TPP) development, due diligence projects, and clinical - regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities … more
- Merck & Co. (Rahway, NJ)
- …of experience in global patient advocacy and engagement activitiesUS/global experience in regulatory affairs , medical and scientific affairs , and ... or public health organizations and their leadersRequired Skills: Advisory Board Development, Clinical Affairs , Clinical Development, Clinical Trials,… more
- Novo Nordisk Inc. (Seattle, WA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Insmed Incorporated (NJ)
- …standards.Cross functional collaboration will be vital as you partner with Discovery, Clinical Development, Quality, Regulatory Affairs , Operations, and ... and commercial supply chains.Your responsibilities will include supporting global CMC regulatory strategies that align with our clinical and commercial… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …commercial strategy.Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical , and Program Management.Maintain ... toxicology strategy from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related field (Master's degree preferred) 3+ years of experience in pharmaceutical training, clinical research, or regulatory affairs ATD certification a ... About the Department The Clinical , Medical and Regulatory (CMR) department...organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing… 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)
- …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
- 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
- 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
