- Merck & Co. (Rahway, NJ)
- …Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director ... Management, Employee Training Programs, FDA Regulations, Life Science, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Policy Implementation, Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer 2026. This full-time ... are seeking a detail-oriented and tech-savvy student to join our Global Regulatory Affairs Labeling Operations team as an intern.The Global Regulatory … more
- Eisai, Inc (Nutley, NJ)
- …broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration strategy/submissions. ... Transparency Language:The annual base salary range for the Director, Global Regulatory Affairs , Growth Markets is from :$200,800-$263,600Under current… 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 ... preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical… more
- 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 ... for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global … more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs , CMC will be responsible for reviewing the CMC post ... approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders...assessments, and coordinating with regional RA-CMC leaders to formulate regulatory strategies for post-approval changes. This role will also… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director, Regulatory Affairs , supports products in the Oncology therapeutic area as part of a regulatory team.- The individual ... regulatory science and strong communication and analytical skills. Our Regulatory Affairs team bring new medical advancements to the world by facilitating… more
- Insmed Incorporated (NJ)
- …submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs , CMC, Clinical, Quality) to facilitate document ... we're in. Are you?About the Role:We're looking for an Associate, Regulatory Operations on the Regulatory team to help us expand what's possible for patients with… 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 at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Insmed Incorporated (NJ)
- …in IT with focus on healthcare/pharmaceutical industryExperience with medical affairs processes and regulatory environmentsStrong technical knowledge of ... science, we're in. Are you?About the Role:The IT Business Partner for Medical Affairs and Innovation serves as a strategic liaison between Information Technology and… more
- Merck & Co. (North Wales, PA)
- …knowledge of best practices in those areasU.S./Global experience in clinical research, regulatory affairs , scientific and medical affairs , or pharmaceutical ... Oncology, Patient Advocacy, Patient Insights, Pharmaceutical Industry, Pharmaceutical Medical Affairs , Relationship Management, US Regulatory AffairsPreferred Skills:… more
- Merck & Co. (Rahway, NJ)
- …of experience in global patient advocacy and engagement activitiesUS/global experience in regulatory affairs , medical and scientific affairs , and ... Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research. This position executes the patient… more
- Insmed Incorporated (NJ)
- …E xpert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs , drug development, FDA and regulatory guidelines (ie, ... readiness and effectiveness of the team.Strategy Development -Partner across medical affairs and cross-functionally to develop strategy relating to IME and External… more
- Merck & Co. (Rahway, NJ)
- …with cross-functional teams, including research, development, quality control, and regulatory affairs , to ensure comprehensive biophysical characterization of ... Biology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance, Regulatory Compliance, … more
- Merck & Co. (North Wales, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Tris Pharma (Monmouth Junction, NJ)
- …manages prior art searches for targeted technologies or productsPartners with R&D and Regulatory Affairs departments for preparation of Orange Book listings and ... functions and new product development processes (ie, Compliance, R&D, Product Development, Regulatory Affairs , Government Affairs , etc.)Ability to influence… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Qualifications Bachelor's degree in a relevant field (Life Sciences, Quality Assurance, Regulatory Affairs , etc.); advanced degree preferred 7+ years of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Cipla (Fall River, MA)
- …committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs , regulatory affairs , quality assurance, procurement etc. ... management. In collaboration with Cipla commercial, supply chain management and regulatory affairs , responsible for launch planning, launch risk mitigation… more
- Merck & Co. (Rahway, NJ)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Insmed Incorporated (NJ)
- …will be vital as you partner with Discovery, Clinical Development, Quality, Regulatory Affairs , Operations, and Commercial teams to ensure seamless program ... a strategic leader, ensuring that development programs meet scientific, quality, regulatory , and commercial standards, while ensuring execution across internal teams… more
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