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In-depth knowledge of CMC regulatory requirements for Advanced Therapy Medicinal Products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
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You will be a trusted advisor to senior management and provide guidance on a spectrum of regulatory matters at the enterprise level across all of our business units: Square, Cash App, TIDAL, TBD, Proto and Spiral.
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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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Regulatory Science Program Faculty Director - Assistant, Associate, or Full Professor. In addition, the applicant is expected to develop a strong research program, funded by federal and other grants, broadly in the areas of drug development, computational drug discovery and development, or regulatory science.
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Develop the enterprise risk management framework and related policies and processes, ensuring they meet regulatory expectations and are tailored to the business, while also enhancing operational efficiencies.
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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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Familiarity with Artificial Intelligence/ Machine Learning, Robotics Process Automation and Blockchain and their impact on the regulatory environment. We work with complex multinational companies to understand the regulatory landscape and influence business decisions.
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Develops/Reviews Stormwater Management Reports and Stormwater Pollution Prevention Plans (SWPPP) to support regulatory permits; Conversant with regulatory codes, design codes and standards, best management practices, permit requirements and construction practices.
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Collaborate with other Exelixis stakeholders (including Clinical Development, Clinical Operations, Data Management, Medical Affairs and Regulatory Affairs) to ensure appropriate collection and handling of safety data.
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Manage regulatory affairs and ensure regulatory compliance of studies, including Institutional Review Board (IRB), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Data Safety Monitoring Board, Food and Drug Administration (FDA), and/or other funding or regulatory agency reports.
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The current role is for a Senior Director, Regulatory Affairs to join our team and advance our platform. Minimum 8 years of relevant regulatory leadership experience in the biotech and pharmaceutical industry; gene editing/gene therapy drug development program experience is a requirement.
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Reporting to the our CMC Executive Director, the CMC Regulatory Technical Writer, Associate Director/Director will be responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met.
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Experience advising on cryptocurrency and blockchain technology legal issues and have a basic understanding of the relevant legal and regulatory landscape; Supporting the business in a wide range of legal coverage areas, including but not limited to token listings, compliance legal support, product promotion and development, global regulatory matters, contract negotiation, and institutional sales and partnerships.
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Extensive knowledge of regulatory standards (e.g. ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management and records management (e.g. DIA TMF reference model) Strong understanding of TMF processes and awareness of evolving regulatory requirements related to records management to support the development and delivery of a TMF Operations strategy.
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Cultivate and guide Square's legal strategy across several subject matters, including payments, lending, consumer protection, privacy and data protection, IP, marketing, and ecommerce to manage legal risk and ensure regulatory compliance while pushing forward business development.
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regulatory job Title: sr regulatory affairs associate Company: Cardinal Health in Oakland, CA
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