- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs , Tactical Implementation, on the Regulatory Affairs ... possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs , Tactical Implementation, you'll have a critical role in… 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
- Larimar Therapeutics (Philadelphia, PA)
- …consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs , manufacturing and CMC. Our company's strategy is ... the day - we welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4 or More Years of related experience working in data analytics in commercial, regulatory , market access or medical affairs function in a healthcare industry ... and immune disorders. Summary The Associate Director, Global Oncology Medical Affairs , Medical Analytics will be responsible for managing the digital analytics… more
- Unknown (Boston, MA)
- …CMC development programs. The ideal candidate will have a strong background in Regulatory Affairs CMC, with experience leading regulatory strategies and ... collaborate cross-functionally with internal teams to ensure alignment of CMC regulatory strategies with overall development plans and corporate objectives. They… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda… 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
- 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. (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
- 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. (Rahway, NJ)
- …acumen and expertise in data and data standards across Clinical Development, Medical Affairs , and Regulatory Affairs domains. Apply domain knowledge to ... governance standards for data quality, data lineage, security, and regulatory adherence. Conduct gap assessments between current-state and target-state… more
- Eisai, Inc (Chicago, IL)
- …implement recommendations for resolution.Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)Technical Skills RequiredAdvance working ... and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. This… more
- Merck & Co. (Upper Gwynedd, PA)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Management Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5… more
- Insmed Incorporated (NJ)
- … regulatory and internal quality standards.Work closely with Quality Assurance, Regulatory Affairs , Manufacturing, and Analytical team to support timely ... such as Deviations, Change Controls and CAPAs.Work closely with Quality Assurance, Regulatory Affairs , Manufacturing, and Analytical teams to support timely… 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
- Insmed Incorporated (NJ)
- …Are:You have a Bachelor's degree along with 5+ years of experience in Medical Affairs , Regulatory Affairs , or related functions within the pharmaceutical or ... ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality and integrity of all reviewed materials.… more
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