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This role requires the functional understanding of Regulatory Affairs processes and the ability to perform database analysis, uploads and verification into the system to support the Global Regulatory Affairs function, as well as Integra LifeSciences.
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Monitor and provide analysis of export control regulatory developments that affect the University’s export compliance efforts. Facilitate the University’s research efforts by providing direction to faculty and staff while also ensuring compliance with statutory and regulatory requirements.
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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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The Director, Corporate Counsel – Rare Disease will serve as the legal advisor to the US Commercial, Patient Advocacy, Public Affairs, Regulatory, and Medical Affairs teams supporting our Rare Disease Franchise, and will coordinate legal services with the attorney responsible for Canadian support for the Rare Disease Franchise.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved.
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Key ResponsibilitiesStrategy and Execution:Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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Interact routinely and will develop a strong team environment with colleagues throughout GRSRequirements:Ph. D., M.D., PharmD. , MS or commensurate experienceSignificant experience in regulatory affairs (e.g. 3-5 years)Expert understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA for drug development and approval.
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Rocket Pharma is seeking an experienced and highly motivated Associate Director, Regulatory Affairs (USL f or AAV), who enjoys a fast paced, dynamic work environment at the forefront of innovation.
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Keep abreast of regulatory developments and evolving best practices in compliance control. Lead remedial actions to address identified compliance/regulatory breaches. Ensure that Coface employees in the Region are knowledgeable about legal, regulatory and policy requirements, aware of new risks, and committed to Coface's culture of compliance.
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Knowledge of local and federal regulatory compliance associated with golf management. Designed by Arnold Palmer, the Regency at Monroe Golf Course opened in 2002. As the Golf Course Superintendent, you will be responsible for overseeing all maintenance and agronomic practices associated with the golf course Previous supervisory experience is required but qualified assistant superintendents and recently retired turf professionals will be strongly considered.
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Partner with Product teams, Client Technology Services and other architects to design scalable, flexible and supportable technical systems that drive business value for Client Global Regulatory Affairs.
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The Princeton School of Public and International Affairs at Princeton University may have an occasional need for lecturers to teach or co-teach in areas such as International Relations, International Development, Domestic Policy, Global Health, Psychology and Public Policy and Economics and Public Policy during the 2024 - 2025 academic year.
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Princeton University's Center for Policy Research on Energy and the Environment (C-PREE) at the School of Public and International Affairs is looking to hire a Senior Policy Fellow/Environmental J.
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Experience with Agile framework, DevSecOps processes, knowledge of cloud security, GxP, GDPR and other relevant regulatory compliance. Ensure R&D digital products meet both Genmab quality and compliance guidelines, GxP compliance, industry regulations including GDPR.
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regulatory compliance courtroom affairs jobs in Monmouth Junction, NJ
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