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The incumbent will report directly to Head of CMC Regulatory Affairs – Systems and Operations at Gilead. In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
$237,660 - $307,560Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. Maintains an up to date knowledge of Company’s ways of working and SOPs and develops a comprehensive understanding of global CMC regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Senior Advisor/Director in Global Regulatory Affairs – CMC will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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A good understanding of all phases of the drug development process and the interdependencies between Clinical and other functional areas (e.g., CMC, nonclinical/toxicology, Regulatory Affairs etc.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Working closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMS. Provide regulatory CMC expertise for new business development/due diligence activities.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Work closely with internal and external functions such as clinical development, medical affairs, CMC, global regulatory affairs, TGO, sourcing and commercial to seamlessly integrate technical process development activities into the overall working model.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Syner-G has grown its geographical footprint across the globe to be an industry leader in integrated biopharma consulting services across the CMC, Regulatory Affairs and Medical Writing verticals supporting small molecule, biologics and medical device development and delivery.
Part-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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The Program Leader will lead a cross-functional team across clinical operations, regulatory affairs, clinical pharmacology, biomarkers, CMC, non-clinical, and medical to deliver against the program strategy.
Full-timeExpandUpdated 1 month ago - UpvoteDownvoteShare Job
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The candidate should have a passion for working collaboratively with nonclinical, clinical and CMC team members to enable building regulatory strategies for CRISPR-based therapeutics. Develop and execute global Regulatory strategies across nonclinical, clinical, quality and CMC functions, for gene editing therapies, ensuring alignment with corporate objectives/timelines and regulatory compliance.
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Deliver excellence in both strategy and execution of the clinical programs by working closely with internal and external partners in clinical operations, project management, biostatistics, data management, regulatory affairs, nonclinical, CMC, medical writing, and others.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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O Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.
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Janssen Research & Development, LLC, is recruiting for a Director, Global Regulatory Affairs - CMC (1 of 2). Consistent track record and/or deep understanding in developing and implementing successful CMC regulatory lifecycle strategies and seen as an expert on product development and how it is applied to global regulatory strategy.
Full-timeExpandApply NowActive JobUpdated 16 days ago
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