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This position is hybrid and reports to the Sr. Director, CMC Regulatory Affairs. The Manager CMC Regulatory Affairs is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early and late-stage T cell therapies.
$174,000 a yearFull-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Provide scientific and medical expertise to cross-functional teams, including research and development, regulatory affairs, market access, and commercial teams. Ensure compliance with regulatory and ethical standards in all medical affairs activities.
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Advanced degree in pharmacy, regulatory affairs, nursing or other life science is preferred. 5-7 years of experience in Regulatory Affairs, Advertising and Promotion required; manager experience preferred.
Full-timeRemoteExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Join Takeda as a Senior Director, GRA - CMC Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives.
$322,300 a yearFull-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Collaborates with other Regulatory Department functions on biosimilar issues, (eg, CMC, Regulatory Operations, Devices) Provides CMC regulatory oversight in the development, communication, and implementation of global regulatory strategies.
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Responsible for working closely with medical affairs, market access, market research, sales, and HEOR to ensure execution of one vision for the brand commercially. Work with internal and external cross-functional groups (Legal, Regulatory, Medical, Project Management, Sales Training, Consumer Marketing, Market Analytics and Business Insights) and external (Ad Agency, Digital Agency) to insure integration and consistency of professional business strategies and regulatory compliance of promotional materials.
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Provides clinical leadership to multidisciplinary study execution teams drawn from clinical operations, clinical science, biometrics, regulatory affairs, CMC, pharm/tox, drug safety, commercial, and alliance partners.
$345,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval.
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Strong knowledge of project management methodologies, biologics processes and regulatory pathways is required to be successful in this role. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines.
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