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Ensure DM project deliverables are completed on time and in accordance with quality standards and regulatory requirements from study start-up through study closure/archival. The Associate Director, Data Management (AD, DM) will be responsible for ensuring high-quality management of clinical trial data in a rapidly evolving environment, in accordance with industry standards.
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Additionally, the Sr. Director of Regulatory Operations owns the interface between Regulatory Operations vendors, including definition, planning, implementation of the collaboration, as well as day-to-day vendor oversight and budget management.
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Engaging and collaborating with Local Markets, Global Strategic Marketing, Medical Affairs, Value and Access, Analytics and Insights, Competitive Intelligence, Commercial Operations, Clinical Development, Governmental Affairs and Public Affairs to develop and drive the implementation of the digital plan to support global marketing strategy and market development initiatives for PrEP.
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The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.
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Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections Partner with cross functional members across Gilead Pharmaceutical Development & Manufacturing (PDM), including Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC, Finance and Technical Development to ensure successful commercialization of the late-stage portfolio, as well as on time delivery of clinical and commercial product.
$274,635 - $355,410 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We are currently seeking a Regulatory Affairs Associate Director to join our growing regulatory team. Associate Director - 5 - 7 years of experience in Regulatory Affairs (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment.
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Maintain and execute the Global Publication Plan for Gilead in collaboration with Clinical Research, Commercial, DevOps, HEOR, and Medical Affairs. Gilead is hiring an Associate Director level experienced, well-organized professional, who will develop, implement, and manage the strategic publication plans for global clinical studies and non-clinical sources, including HEOR, Epidemiology, RWE, Payer, Non-interventional, and database studies, to demonstrate the value of pipeline and inline products in Inflammation/Fibrosis.
$165,580 - $214,280Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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10+ 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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5+ years experience in role/s operationalizing data policies - e.g. data privacy operations, privacy regulatory compliance, security GRC, Trust & Safety function - executing cross-functional organizational processes in data governance/ digital transformation.
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Familiar with regulatory standards and quality systems (e.g., GLP, GMP). Reports to: Associate Director, Analytical Development, Raw Materials Location: San Carlos, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
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Collaborate with partners in Process Development, Regulatory, and Clinical groups to fulfill company objectives (Tech Transfer, IND filings, IP) Experience with multi-color flow cytometry, panel design, primary cell culture, cell sorting and/or data analysis is preferred.
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As a member of a cross-functional team, GRAIL's Principal Scientist, RWE will build and maintain cross-functional relationships with Medical Affairs, Clinical Development, Regulatory, and business teams; and collaborate with the team effectively to ensure the implementation of rigorous methods and delivery of scientifically sound results, in support of regulatory submissions, publications and/or other uses.
$212,000 - $282,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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MINIMUM of 7 years experience within the asset management industry in a data analyst role with a strong understanding of investment functions from fundamental research, investment compliance, risk management, and regulatory reporting.
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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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Licensed mental health professional as confirmed by state regulatory/licensing board (e.g., LCSW, MFT, RN, or LPCC) from the state of operation. Free CEUs, free Supervision for BBS Associate License, coaching and mentorship.
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regulatory affairs jobs Title: sr regulatory affairs associate in San Mateo, CA
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