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The Regulatory Compliance Director provides strategic leadership for quality culture, inspection readiness, clinical to commercial transition, and escalation process for the CDMO business unit.
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Required Experience:For the Senior Director level we require:MD, PharmD, PhD with 10+ years of experience in Hematology/ Oncology or an MA/MS with 15 + years of experience in Hematology/ Oncology.
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Work with the Inclusive Growth department’s Senior Vice President and Managing Director to set the strategic direction for the Women’s Initiative team. The Senior Director must be experienced in policy strategy development and execution—including design, analyses, and recommendations—and rapid-response commentary.
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The Director of Risk Management and Regulatory Affairs (Patient Safety Officer/Privacy Officer) serves as an accessible resource to the hospital and community on risk management and regulatory issues.
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The Regulatory Affairs Technical Writer supports projects related to Curium's business strategy in the space of sterile drug manufacturing including reactor and cyclotron derived new products.
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The Vice Provost of Academic Affairs is part of the academic leadership team comprised of the Vice Provost of Student Affairs, Vice Provost of Enrollment Management, the Department Chairs, the Associate Vice Provost of Student Success, the University Registrar, the Director of Sponsored Programs, the Graduate Program Coordinator, and the Director of Academic Affairs.
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The Director, State Affairs influences public and government policy at all state government levels. Represent Humana at regional and national legislative, regulatory and other intergovernmental organizations in coordination with State Affairs policy team.
$185,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Renewables Regulatory Policy Leader, ERCOT & Southwest (Director-VP level talent) Utility-scale renewable energy regulatory affairs and market policy experience working with IPPs / Developers / Owners.
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Reporting to the Chief Creative Officer, the Senior Marketing Director at Powder will lead marketing efforts for Powder as an overarching parent brand, that includes real estate, ski resort, and the emerging art program.
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Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. JOB DESCRIPTION Job TitleSr. Regulatory Affairs Specialist-CT/AMIJob DescriptionThe Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy.
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Experience in a nonprofit advocacy organization, trade association, state legislature or Congress, state, or federal agency, working in a corporate government affairs office or trade association.
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You're the right fit if: You’ve acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K’s, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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Regulatory Affairs representative for the CT/AMI Systems and assists with regulatory issues related to such items as labeling and marketing ideas, claim development and prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for a program.
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Bowdoin - Senior Vice President and Dean for Student Affairs Bowdoin College seeks an experienced, thoughtful, energetic, creative, and collaborative senior vice president and dean for student affairs (SVP/DSA) with the highest standards of excellence and integrity.
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The Associate AD - Governance and Regulatory Affairs provides leadership and oversight of the compliance, ethics and integrity program for the University of Wisconsin-Madison's Athletics Department.
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Title: senior director regulatory affairs Company: Galera Therapeutics
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