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Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist (Associate Director) is responsible for Regulatory Chemistry Manufacturing & Controls (CMC) aspects of clinical phase through market product registration for the assigned portfolio of small molecule, biologic, biosimilar and/or combination products which are acquired or licensed externally as a key component of the company growth strategy.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Mentors and provides oversight to junior department members supporting Commercial Regulatory Affairs activities. Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval, and implementation of promotional materials and other related activities with an increased level of independence.
$255,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Planning, compiling, publishing and submitting Regulatory documents for IND, NDA, BLA, IDE, and PMA applications, including Amendments, Supplements, and Meeting materials to the FDA. Have at least 7 years of experience in Regulatory Operations/ electronic submissions.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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You will provide timely and proper investment reporting of General Account Invested Assets under applicable Statutory, GAAP, Management and Tax basis.
$120,700Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Interact with CMC regulatory affairs personnel to gain knowledge on timelines and resource needs across the biopharmaceutical portfolio. Develop and maintain a detailed CMC regulatory dashboard to support program timelines, deliverables, and risk profiles across the portfolio.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips’ Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and significant post market changes.
$178,000 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Purolite is seeking a Global Biopharma Regulatory Consultant who will work with multiple internal teams and external stakeholders and contribute to supporting our bio pharma customers with their filings and working with governmental bodies.
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The Safety Manager - Regulatory Compliance will lead a cross functional team that handles critical regulatory compliance programs throughout AmeriGas. The compliance responsibilities include Process Safety Management (PSM), Risk Management Program (RMP), Office of Pipeline Safety (OPS), and Department of Homeland Security (DHS) related activities.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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As a CMC Regulatory Affairs Manager, you will get the opportunity to be working with biologic products such as monoclonal antibodies and ADC's across all stages of product development, early to late clinical stages through to BLA (Biologics license application.
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Liaises and negotiates with health authorities as needed for all aspects pertaining to drug development including novel regulatory pathways for the company's gene therapy products, resolution of key regulatory issues and to expedite approvals of products.
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This position will lead regulatory analysis and support engagement with regulatory agencies including but not limited to Centers for Medicare & Medicaid Services (CMS), Food and Drug Administration (FDA), and other relevant agencies within the Department of Health and Human Services (HHS.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Johnson & Johnson is recruiting for a Principal Scientist, CMC Regulatory Affairs to be located in Raritan, NJ; Titusville, NJ; Horsham, PA; Malvern, PA or Spring House, PA. The Principal Scientist, CMC Regulatory Affairs provides support for the registration activities for a diverse portfolio of biologic drug products.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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They will actively participate in the development and management of the Regulatory Affairs (REG) department within the Value Delivery Centre (VDC) REG, in relation to the SPM and CMC Practice Areas.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Position Title: Senior Regulatory Affairs Specialist – RA/QA - Position location/Corporate Office in Malvern, PA. The Senior Regulatory Affairs Specialist is primarily responsible for leading and assisting with various regulatory submissions, authoring, and editing regulatory documentation and procedures, and participating in compliance activities.
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Title: regulatory Company: Impact Legal Resources in King Of Prussia, PA
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