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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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Bachelor’s degree in life science and 10+ years of experience in regulatory affairs in the pharmaceutical/biotech industry. Regulatory expertise in project leadership, preferably negotiation with and conduct of meetings with the FDA and successful preparation and submission of IND/CTA/MAA/NDA/BLA with explicit CMC focus for biologics and/or small molecule modalities.
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As the Director of Congressional Affairs, you will work closely with the Senior Vice President for Federal Affairs to ensure that City Year/Voices for National Service is a highly visible, trusted, and influential resource on Capitol Hill and with the Executive Branch.
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The Director will closely collaborate with cross-functional partners including Regulatory, Clinical Research, Clinical Operations, Biometrics, Medical Affairs, Patient Advocacy, and Commercial to successfully incorporate HEOR strategies and RWE to support the development and commercialization of our asset in CAH.
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The Head of Regulatory Affairs US will report to the Head of Legal Affairs US. This position will handle a wide range of regulatory affairs matters, including providing legal advice and counsel across various sectors, functions, and business units both in the United States and internationally.
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The Legislative Affairs Manager will serve as a junior lobbyist on the legislative team. Job Description Legislative Affairs Manager: NRECA is a unique national trade association providing advocacy, financial services and business support services to over 900 consumer owned electric cooperatives across the country.
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The Senior Director, QARA is principally responsible for the development and implementation of the Company’s quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping Third Party Logistics VP of Quality Assurance & Regulatory Affairs informed on quality assurance and regulatory affairs matters.
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Director/Sr. Director, Regulatory CMC | Seattle, WA | Just-Evotec Biologics is seeking a Director/Sr. Director of Regulatory CMC to join a fast-paced, collaborative and multi-disciplinary team to lead all aspects of regulatory affairs for the advancement of low-cost biotherapeutics manufacturing.
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The Director, Regulatory Genomics will have demonstrated expertise in regulatory writing and strategy as well as health authority interactions both written and verbal with a focus on genomics and genotoxicity evaluation.
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Develop and implement project outreach plans, outreach budgets and other materials in coordination with PSEG Long Island External Affairs Regional Managers and other internal groups as appropriate.
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Strong command of the drug development process, regulatory environment, and legal and compliance regulations governing Medical Affairs activities is required. As a key member of the Global Medical Affairs (GMA) Leadership Team, the CMO contributes to the development and execution of the GMA Strategy, maximizing the value of Kyowa Kirin medicines for patients.
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Minimum of 10 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education.
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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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Serves as University Ambassador for special programs sponsored by the Chancellor's Office, Academic Affairs, Advancement, Student Affairs, University and Community Relations, Business Affairs, Athletics, and other areas, as requested.
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Position Overview QinetiQ U.S. seeks a junior Strategic Communications and Public Affairs Analyst responsible for managing an integrated marketing communications and public affairs portfolio on behalf of a federal law enforcement organization within the U.S. Department of Homeland Security.
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regulatory affairs jobs Title: sr director Company: Kelly Services
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