- Legend Biotech USA, Inc. (Raritan, NJ)
- …project management in cross-functional drug development teams or clinical, regulatory , pharmaceutical sciences/technical operations in the biopharmaceutical ... entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize… more
- Merck & Co. (Rahway, NJ)
- …in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical /Biotech industry OR Master's degree ... in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical /Biotech industry ORPh.D. in Chemical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …preferred Advanced knowledge of pertinent FDA regulations Broad hands-on related pharmaceutical experience and FDA regulatory experience; subpart H experience ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...preferred A minimum of 7 years of experience in pharmaceutical /biologics industry or related field required, with 5 years… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of those most recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) A minimum of 7 years ... 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
- Lundbeck (Chicago, IL)
- … Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures ... and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …healthcare related fields is preferred A minimum of eight (8) years combined pharmaceutical , legal, regulatory , and compliance experience required OR a minimum ... to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ethical & privacy standards and ensuring… more
- Lundbeck (Rockford, IL)
- … Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to ... policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of… more
- Lundbeck (Fargo, ND)
- … Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to ... policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of… more
- Tris Pharma (Monmouth Junction, NJ)
- …with advocacy organizations and Key Opinion Leaders (KOLs)Strong understanding of pharmaceutical marketing practices including the regulatory environment and ... payor landscape and pricing, distribution, promotion etc.Deep knowledge of the pharmaceutical Legal, Medical, Regulatory review processDemonstrated experience in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …communications experience within regulated industries A minimum of 6 years combined pharmaceutical , legal, regulatory , and compliance experience required OR a ... to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ethical & privacy standards and ensuring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Ph.D., MD, JD) preferred. Experience Qualifications:10 or More Years in the pharmaceutical industry required.8 or More Years in regulatory affairsExperience in ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Genmab (Plainsboro, NJ)
- …for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily ... responsible for the development of global (and US) regulatory strategies (depending on the assigned project/projects) to advance Genmab's portfolio of development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory AffairsKnowledge of ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other related discipline preferred Experience Qualifications:10 or More Years in the pharmaceutical industry required7 or More Years in regulatory affairs; ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources , and stability, uniting the best of both ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharm.D., Ph.D., MD, JD) preferred Experience Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs, NDA, sNDA, BLA ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... Regulatory Affairs organization.In this role, you will work in...Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Director of Regulatory Affairsis a strategic leader responsible for directing and managing regulatory strategies for multiple pipeline and ... role in interactions with the FDA, EMEA, and other regulatory agencies to drive product approvals and maintain correspondence...10+ years of relevant and current work experience in pharmaceutical / biotech / CDMO industry in a fast-paced… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You will spearhead regulatory ... Primary responsibilities include, but are not limited to: Serve as the Regulatory Project Lead for assigned device and combination products, guiding cross-functional… more
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