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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
$286,700 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reporting to the Senior/Executive Director or Vice President of Regulatory Affairs, the Director of Regulatory Affairs – CMC and Compliance will be responsible preparing CMC regulatory strategies that enable first pass approvals.
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Reporting directly to the Sr. Director, Global Medical & Scientific Affairs (GMSA), Abbott Point of Care. Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams.
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Associate Director, Medical Affairs Cell Therapy, Franchise Strategy And Operations, Project Manager
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The Associate Director, Strategy and Operations is responsible for partnering with colleagues in Medical Affairs and in other functions including Commercial, both Heme and Cell Therapy to lead or support Strategic Planning responsibilities.
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Rocket Pharma is seeking an accomplished and strategic Senior Director of Regulatory CMC to lead our Chemistry, Manufacturing, and Controls (CMC) regulatory affairs. The ideal candidate will possess extensive experience in CMC regulatory affairs, particularly in writing CMC sections for INDs, NDAs, BLAs, and MAAs, as well as strong leadership skills.
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Efficient delivery of all aspects of business operations including but not limited to Commercial Operations, Patient Services, Clinical Development, Sales & Marketing, Market Access, Corporate Communications/Patient Advocacy, Sales Training, Commercial Digital Analytics, Medical Affairs, Regulatory Affairs, Sales Ops, Supply Chain, Drug Safety and Finance, Legal and Quality Assurance.
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
$190,625 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
$284,375 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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Novo Nordisk’s Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions that drive patient access to innovative products.
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This role will be a pivotal one in helping Thermo Fisher Scientific grow as a leader in the stem cell-derived therapeutic space, especially in enabling the development of allogeneic cell therapies.
$137,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The Director, IP Counsel will report to the Senior Director, IP Counsel in the Intellectual Property Practice Group in Legal Affairs. Develop and communicate IP guidance to stakeholders across the business, including within Clinical Development, Medical Affairs, Business Development, Commercial, Marketing, and Legal Affairs.
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Advise the Vice Provost for International Affairs and other University leaders on emerging andor urgent threats and risks to University interests stemming from geopolitical or other safety and security developments in the United States and abroad.
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affairs job Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Princeton, NJ
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