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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that is improving the field of diagnostic imaging and saving patient lives. Senior Regulatory Affairs Specialist-Remote Based-West Coast.
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We are looking for an Associate Director/Director, Regulatory Affairs CMC to join our team. Minimum 8-10+ years progressive Regulatory Affairs experience; 6+ years with an advanced science-related degree.
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Reporting to the Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs – CMC will be responsible for leading, developing, and executing CMC regulatory strategies on programs ranging from early to late-stage development, including preparation and filing of IND and NDA/MAA submission.
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A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or10 years with an MA/MS, PhD, PharmD, or MD.
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We are seeking an innovative and highly motivated Principal Scientist, Scientific Affairs who will contribute significantly to the development and continued growth of our advanced cell therapy manufacturing platform.
$90,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Under the supervision of the Regulatory Program Manager (RPM) of the Regulatory Affairs Unit, the Regulatory Affairs Coordinator (RAC) supports the clinical research efforts of the Chao Family Comprehensive Cancer Center by providing comprehensive, regulatory management of cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures.
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Drive awareness among Pfizer senior leaders of the value created / ROI from oncology development-focused AI/digital technological innovation, and work with Oncology Scientific Affairs and Strategic Partnerships colleagues on external communications on these topics.
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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Experience in advertising and promotional regulatory affairs activities through launch and commercialization are a plus. The VP, Regulatory Affairs will provide strategic regulatory expertise to support the continued development and the commercialization of acoramidis for the proposed treatment of ATTR-CM and the prevention of ATTR. This role involves collaboration with cross-functional project teams in planning and execution of development strategies while providing leadership to global regulatory submissions.
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Reporting to our VP of Business & Legal Affairs, Content and Games, you will manage various business and legal affairs for Crunchyroll, with a focus on anime licensing and co-production agreements with Japanese licensors and production committees.
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Errors or omissions may ultimately place research participant at undo risk and / or compromise the institution's assurance of regulatory compliance with the federal government. While the Division is primarily split between the Parnassus and Mission Bay campuses, clinical fellows have rotations at the Zuckerberg San Francisco General Hospital and the San Francisco Veterans Affairs Medical Center.
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Establish appropriate strategic partnerships with internal leaders in clinical development, regulatory affairs, safety, operations, research, and commercial. Collaborate with legal, compliance, and regulatory authorities to ensure proper and ethical interactions between medical affairs personnel and external stakeholders.
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Drive awareness among Medical teams of the value created / ROI from oncology development-focused AI/digital technological innovation, and work with Oncology Scientific Affairs and Strategic Partnerships colleagues on external communications on these topics.
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If you are passionate about crypto regulatory compliance and looking for in-house legal jobs in San Francisco, this role could be an exciting opportunity to work on novel legal and regulatory challenges in the digital currency industry.
$208,400 - $254,700 a yearFull-timeExpandApply NowActive JobUpdated 28 days ago
regulatory affairs jobs Title: sales representative Company: Vector Marketing in South San Francisco, CA
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