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Provide regulatory guidance, general issue management and strategic stakeholder engagement support to Corporate Affairs and business leaders. Humana Director Public Policy, State Affairs in Juneau , Alaska Become a part of our caring community and help us put health first.
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Humana Director Public Policy, State Affairs Bismarck , North Dakota Apply Now Become a part of our caring community and help us put health first. Reports to the VP, Strategy & State Affairs-Corporate Affairs Administration.
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Position Summary:The Pennsylvania Director of State Affairs serves as the principal staff for state government affairs and chief lobbyist in Pennsylvania, representing the Alzheimer’s Association before Pennsylvania’s legislature, governor, relevant state agencies, community stakeholders and coalitions, and on statewide task forces and work groups.
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Use project management techniques to identify, develop, and maintain planning tools (e.g. spreadsheets, MS Project, MS Teams, Smartsheets) in support of CMC regulatory/ product development projects.
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A degree(s) in business, communications, marketing, public relations, government affairs, political science, technical area of specialty or relevant field may be substituted per LCRA guidelines for certain years of experience.
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Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC. A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs CMC.
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Engages with cross-functional team members in Clinical Affairs, Operations Center of Excellence, Professional Affairs, Health Economics and Market Access, R&D, Regulatory, and Medical Safety and Infection Prevention & Control to review clinical evidence and to evaluate a product’s risk-benefit calculus.
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In coordination with the Associate Dean of Students, the AVPDOS oversees the establishment and training of hearing panels, assures the adjudication of student code of conduct violations, and coordinates the Division of Student Affairs response to student emergencies.
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Recruiting Practice Director, Regulatory Affairs (Pharma) Experience placing Regulatory Affairs professionals in CMC, Ad Promo, Labeling, Regulatory Strategy, etc. Cultivating long-term partnerships with key stakeholders in Regulatory Affairs.
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The Senior Director serves as a member and contributor to various business unit teams, providing functional expertise and leadership, and actively contribute to the business as a whole; Cross functional partners, including R&D, GSM, US marketing, Business Development, Medical Affairs, Clinical Research, Regional HEMA & Marketing, Regulatory Affairs, HCC and Legal.
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Assist in the preparation and drafting of testimony, regulatory comments, and position statements sent to legislative and regulatory bodies and other interested parties concerning legislation, policies, published reports, regulations, and statutes governing Medicaid, long-term services and supports (LTSS), and other waiver programs.
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Author product statements and documentation in compliance with international and country specific legislation (e.g. product dossiers, registration certificates) with the support of the SDS authoring specialist for label data, GHS classifications, Dangerous Goods classifications, worker safety or environmental risk assessments and with the support of the Regulatory affairs team for site specifics and environmental regulation.
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Experience in academic affairs, advising, student support services, enrollment management or student affairs. The AVPAA will report to the Provost and Vice President for Academic Affairs, working closely with the senior academic team to reinvigorate the institution's student success agenda.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Jobot
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