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As Senior Regulatory Affairs Manager, Pharma within the North America region, you will be part of a cross-functional team, based in Plainsboro, NJ. The activities linked to the position are highly complex due to the dynamics of the North American market and changing regulatory environments.
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Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) As a key member of the Regulatory Affairs leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company.
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Importantly, the chosen candidate will manage and mentor a group of Regulatory Affairs strategists. Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
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Manager - Regulatory Affairs CMC page is loaded. Manager - Regulatory Affairs CMC. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies.
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The FRM will need to coordinate cross functionally within Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, and Specialty Pharmacy Account Management.
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Provides oversight of Amicus’s External Manufacturing activities, working in partnership with Technical Operations and Regulatory Affairs to ensure compliance of outsourced activities with Amicus procedures, and Global Regulations and Guidance.
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Lead project teams to manage and support various projects such as digital health, academic training programs, and Professional Associations/Public Affairs/Policy initiatives. The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization.
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Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs , Drug Safety and Pharmacovigilance, Legal , Commercial, Sales and Marketing, etc.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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In this role, you will lead the legal support, including directly advising, educating BMS colleagues, staying current on evolving global regulatory, legal and policy environment for BMS’ work with digital solutions, including regulated patient and physician-facing digital health solutions (e.g., digital medicine and digital therapeutics) such as mobile applications, diagnostic algorithms, digital biomarkers, use of artificial intelligence and clinical decision support solutions.
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Strong command of the drug development process, regulatory environment, and legal and compliance regulations governing Medical Affairs activities is required. As a key member of the Global Medical Affairs (GMA) Leadership Team, the CMO contributes to the development and execution of the GMA Strategy, maximizing the value of Kyowa Kirin medicines for patients.
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Princeton University's Center for Policy Research on Energy and the Environment (C-PREE) at the School of Public and International Affairs is looking to hire a Senior Policy Fellow/Environmental J.
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Work in cross functional teams (e.g. Product Development, Marketing, IT, Procurement, External Affairs, Regulatory) to develop and maintain environmental sustainability and safety initiatives by providing expert advice, modeling, calculations, and documentation.
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Partner with Product teams, Client Technology Services and other architects to design scalable, flexible and supportable technical systems that drive business value for Client Global Regulatory Affairs.
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Licensed Speech Language Pathologist, State of New Jersey Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech Pathology Advisory Committee pursuant to NJSA and NJCA. This includes a temporary license as approved by the NJ DOH personnel standards for early intervention personnel.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Gpac in Lawrence, NJ
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