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This role is part of a global cross-functional team and interacts with Global Clinical Development, Clinical Management, Regulatory Affairs, Biostatistics, Global Medical Affairs, Commercial, Market Access, Government Affairs, and other colleagues to stay abreast of clinical development program needs for value differentiation in alignment with the target product profile across the product lifecycle.
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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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The Scientific Affairs Manager will also liaise with cross-functional team members including clinical, regulatory, quality, legal, supply chain and will be responsible for managing individual study budgets/milestone payments.
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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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Must be able to effective articulate and negotiate complex project related matters to FDA. Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations.
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Minimum of 10 years of experience in regulatory affairs, with at least 5 years in advertising and promotion compliance. The Director, Regulatory Advertising & Promotion is responsible for ensuring that all promotional materials and activities comply with the applicable laws, regulations, and guidelines in the US. You will be responsible for the review of promotional materials, providing strategic guidance to the commercial teams, and interacting with FDA's OPDP on advertising and promotion matters.
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Program Manager collaborates with the Financial Management Office at the Princeton School of Public and International Affairs and Princeton University's Office of Research & Project Administration.
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The Project Manager, Regulatory Affairs Global Compliance and Planning is responsible for driving implementation of and adherence to best practices in project management.
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Engage, as directed, with internal stakeholders (e.g. multidisciplinary project groups) and external stakeholders (e.g. external experts and partners around emerging landscape; regulatory authorities.
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Drives WMT executive reporting, risk routines, analytics, and proactive insights across the risk portfolio (i.e. RISE compliance deliverables, Third Party Risk Management, regulatory/audit/issue management, infrastructure vulnerabilities, non-permitted technology, Global Information Security findings, and Disaster Recovery plans and continuity testing.
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Train and obtain access on company tools and systems that support contracting, PO, and invoicing for regulatory affairs in the US and EMEA. Support budget tracking as directed by company DRI Efficiently prioritize and manager multiple tasks, ensuring all tasks are completed within the given deadlines.
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Business partner to R&D, regulatory affairs, and business development teams on product development and drug approval pathways, and on R&D and commercial issues. The Senior Director, Head of Regulatory Law reporting to the VP, General Counsel will provide regulatory counsel to the Rx, Generic, and OTC business at Sun Pharmaceuticals, and its affiliates including Taro Pharmaceuticals.
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Manage schedules and streamline work between all team members and agencies including internal creative development project briefings to collect information in order to drive the discovery process with creative, strategy, production, development, regulatory, QA teams to deliver projects in a timely manner.
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Other internal relationships include those with Medical, Sales, Regulatory, Legal, Market Access, Global Marketing and Global Medical. The Position The Senior Manager – New Product Commercialization (NPC) and 5D will lead and execute strategic and tactical elements of commercialization of assets from T-3 years to launch in Rare Disease.
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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Gpac in Hopewell, NJ
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