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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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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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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.
$100 - $113 an hourFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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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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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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The Verantos Evidence Platform leverages data science and artificial intelligence (AI) along with advanced data sources such as electronic health records (EHR) to generate RWE capable of supporting complex clinical studies in areas such as market access, HEOR, medical affairs, and regulatory engagement.
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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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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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POSITION SUMMARY Reporting to the Managing Counsel, Health Affairs, Privacy & Data Protection Law, the Principal Counsel - Health Regulatory provides primary legal support to the University's medical centers and health sciences schools on complex and high impact healthcare regulatory analysis.
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The VP, Regulatory Affairs will work in conjunction with various stakeholders across functional areas within the company and with external commercialization partners. Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA, as applicable) in compliance with all applicable regulatory requirements and alignment with corporate goals.
$305,000 - $365,000 a yearFull-timeExpandApply NowActive JobUpdated 27 days ago
regulatory affairs jobs Title: sales representative Company: Vector Marketing in San Francisco, CA
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