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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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This position is based in our Princeton, NJ office with onsite presence 60% of the time and reports to the Head of Regulatory Affairs. Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred.
$343,750 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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With 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience. Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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BA/BS degree or equivalent, at least 6 years pharmaceutical industry experience, and prior Regulatory Operations experience required. Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
$159,375 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Act as Regulatory Affairs representative and expert for US regulatory requirements for early and/or late-stage development projects within the radiopharmaceutical pipeline, with prime focus on upcoming NDA submission(s.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Participate in the development of the CMC regulatory strategy for biologics submissions.
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Senior Associate, Regulatory Affairs, Dietary Supplements. The Senior Associate, Regulatory Affairs is responsible for developing regulatory strategy and providing guidance to product development and commercial teams in support of Kenvue’s Dietary Supplement Portfolio.
$152,000 a yearFull-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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The Cannabis Regulatory Commission (CRC), Office of the Chief Counsel/Regulatory Affairs seeks a Regulatory Officer 1 to assist in the drafting, coordinating and revising of rules, regulations and orders that may be required to implement the statutory authority, powers and duties imposed upon the CRC. RESPONSIBILITIES: Assist the supervisory official in advising the CRC concerning the application of various statutes, federal and state.
$111,000.8 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Position The Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is a one-year, experiential program based in Plainsboro, New Jersey. Essential Functions General All fellows will complete a fellowship project for presentation to the Regulatory Affairs department and/or at a key conference/congress.
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The Regulatory Affairs Specialist is responsible for implementing regulatory strategies for the Company with a focus on achieving compliance with all current and upcoming regulations in the US and EU. The Regulatory Affairs Specialist is responsible for providing regulatory input for regulatory documentation and development or sustaining projects to ensure that regulatory requirements are met.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Senior Director, Global Regulatory Affairs Strategy. Work closely with regulatory CMC lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are aligned.
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Job Title: Senior Regulatory Affairs Specialist. Certifications: RAC (Regulatory Affairs Certification) from the Regulatory Affairs Professionals Society is preferred but not required.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Seeking a Senior Regulatory Affairs Specialist to join our team. Experience in Regulatory Affairs specific to In Vitro Diagnostic (IVD) Devices. Regulatory Affairs certification (e.g., RAC) is a plus.
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Step into a pivotal leadership role (VP Level) where your expertise in regulatory affairs will shape the future of a transformative biopharma company. Building and mentoring a high-performing US Regulatory Affairs team.
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affairs job Title: regulatory in Lawrence, NJ
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