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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 23 days ago - UpvoteDownvoteShare Job
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Regulatory, Legal/Compliance, Medical, Marketing, Creative Agencies. Perform other regulatory tasks as assigned. Intra-Cellular Therapies is a biopharmaceutical company committed to the development of novel CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co-founder and Nobel laureate, Dr. Paul Greengard.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Manager, Regulatory Affairs: Base Salary Range $90,000 - $120,000. Onboard and conduct Veeva system and standard operating procedure (SOP) training for Internal and External parties. Ensure all promotional materials are properly vetted through the review process utilizing the cloud-based review system (Veeva PromoMats.
$120,000 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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The Medical & Scientific Affairs Lead - OTC provides expert medical and scientific support to multiple departments and interdepartmental teams including R&D cross functions, Innovation, Marketing /commercial, Clinical Development, Regulatory, Category, BU’s etc.
$297,238 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with regulatory strategy for cell therapy clinical CMC regulatory submissions based on high quality technical reports.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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This individual will be responsible for delivering CMC documentation (Dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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CMC regulatory affairs, or a related field within the pharmaceutical or medical device industry. Specific certifications related to drug-device combination products or regulatory affairs (e.g., Regulatory Affairs Certification) could be advantageous.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The position interfaces with experts in Process Development, Analytical Development, Manufacturing Sciences and Technology, Operations, Quality and Regulatory Sciences. Experience with regulatory documentum software (CARA, eSub, etc) is strongly preferred along with proficiency in compliance ready standards for final publication.
ExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Accountable for collaboration with cross-functional teams, including research and development, legal, regulatory affairs, and business development, to ensure IP considerations are integrated into product development and commercialization strategies.
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Partner with SME organizations to identify source documents and negotiate delivery of approved technical documents in accordance with project timelines and aligned with CTD requirements and regulatory strategy.
ExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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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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The Scientific Director, US Medical Affairs, Endocrinology will serve as a scientific/medical expert to lead and manage strategic initiatives and projects that integrate Recordati’s scientific, clinical data into programs that drive business and medical affairs priorities.
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Worker manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. Worker defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global Sanofi locations or contract manufacturing organizations (CMOs), or alliance partners.
$50 an hourExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Strong experience in VEEVA, life-cycle tools & regulatory affairs. He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs.
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He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global Client locations or contract manufacturing organizations (CMOs), or alliance partners.
$50 an hourExpandApply NowActive JobUpdated Today
regulatory affairs jobs Company: Mallinckrodt Pharmaceuticals in Raritan, NJ
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