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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.
$142,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Kelly® Science & Clinical is seeking a Regulatory Affairs Associate for 1 year contract position (with possibility of extension) position at a premier client in Skillman, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
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This position reports directly to and works closely with the Head of Legal Affairs, and you will have regular interactions with the General Counsel and other senior leaders within the business.
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Work closely with the Head of Legal Affairs and other members of the legal team, strategically manage legal issues with and without external counsel, and provide legal advice to business leaders throughout the company.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Ensure that all medical affairs activities are compliant with policies and processes. Support Head of Eliquis WW Medical Affairs in development and oversight of the cross-matrix execution of the annual medical plan and associated medical deliverables.
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Associate Director, Regulatory Affairs Operations Pleasanton, CA, USA ● Princeton, NJ, USA Req #386. Under the leadership of Regulatory Affairs, the incumbent manages global regulatory operational activities (except Asia) for all Taiho Oncology, Inc., (TOI) projects, provides strategic regulatory operational guidance during drug development, approval, post approval, and commercialization, in coordination with internal staff and external consultants/contractors.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Regulatory Affairs Labeling Associate Level is needed to prepare and review regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Sandoz internal practices.
$57 an hourExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Minimum of 5 years’ experience in Regulatory Affairs and pharmaceutical clinical development; preferred experiences in oncology an autoimmune therapeutic areas. Science degree (e.g. Chemistry, Biochemistry, Molecular Biology, Biotechnology, Biology, Pharmacy) or equivalent; advanced degree desired.
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The project portfolio at Genmab is evolving, and we are therefore looking for a Director/Associate Director to join the Regulatory Affairs CMC team. Director/Associate Director, Global Regulatory Affairs - CMC.
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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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