- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry required7 or More Years in regulatory affairs ; experience in US regulatory affairs from IND ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... related to final printed pharmaceutical labeling for launch and lifecycle management projects guided...The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global… more
- Genmab (Plainsboro, NJ)
- …looking 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 ... of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs , the key responsibilities… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …relating to compliance efficiently and with utmost professionalism. The Director of Regulatory Affairs will also interact with many consultants, Exela's contract ... submission of regulatory dossiers. The Director of Regulatory Affairs will participate in discussions on...10+ years of relevant and current work experience in pharmaceutical / biotech / CDMO industry in a fast-paced… more
- Genmab (Plainsboro, NJ)
- …essential 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...Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... rapport and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ colleagues regarding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA Travel Ability to travel up ... 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience with ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Merck & Co. (North Wales, PA)
- …and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional ... practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve as the liaison and manages correspondence with… more
- Genmab (Plainsboro, NJ)
- …information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy ... and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading… 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
- Genmab (Plainsboro, NJ)
- …US healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross functional ... authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors Strategy will report to the Senior Director, US Medical … more
- Novo Nordisk Inc. (WA)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …maintaining technical training programs related to GxP, Clinical, Medical and Regulatory affairs , Patient Safety required A thorough understanding and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...12+ years of progressive Training & Knowledge Management in Pharmaceutical environment required Five (5) or more years of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs , Sales, Marketing, Market Access, etc.) including, but not limited to,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Tris Pharma (Monmouth Junction, NJ)
- …in positions of increasing technical and strategic responsibilityExcellent working knowledge of regulatory and industry standards related to Medical Affairs role ... small MSL team. Collaborating closely with, and reporting directly to, VP/Medical Affairs in developing medical strategic and tactical plans the incumbent supports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... templates, reviews agreements, and manages outside counsel as necessary. Global Government Affairs Acts as legal advisor for Government Affairs groups within… more
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