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Incredible opportunity to bring your experience leading CMC Regulatory strategies and your Biologics expertise to Parexel! D., Masters and Ph. D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology- RAC certification a plusExperience:- 7 years or more of CMC regulatory experience in the pharmaceutical industry with a history of successful of investigational filings and approvals of marketing applications as the CMC Regulatory lead.
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Bachelor of Science, International Affairs/Foreign Affairs or similar field with 4+ years of relevant experience OR a Master of Science, International Affairs or similar field with 2+ years of relevant experience.
$124,550 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Works in collaboration with Enrollment Management Team, Student Affairs, and Academic Affairs to propose, analyze, and update policies related to academic records. Provides leadership and guidance for all initiatives to advance services provided by the Academic Records and International Student Support team.
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The person in this role specifically interacts with the Faculty Directors of McCourt academic programs, the Associate Dean of Student Affairs, McCourt Communications and Events staff, student organization leaders, and numerous student resources at Georgetown as they support McCourt students and the Office of Student Affairs suite.
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Specific responsibilities include Quality Systems, FSMA, HACCP, GFSI/BRC, regulatory audits, food safety training, Regulatory Affairs, Plant Quality Assurance, Vendor Compliance, and Consumer Affairs.
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Ability to integrate public policy advocacy with public affairs, communications, business strategy and corporate development. Experience working in state government or leading policy or public affairs work for third-party organizations (e.g., lobbyist or running campaigns.
$198,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Senior Manager, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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Experience in one or more of the following policy areas bank prudential regulation (i.e., capital, leverage, and liquidity), market regulation (i.e., derivatives, securities), ESG, digital assets, cybersecurity, artificial intelligence, or expertise on the operations of the U.S. Congress and the U.S. government, including through a previous U.S. government affairs role.
$175,000 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Two (2) years of progressively responsible experience in regulatory affairs, legislative affairs, or energy policy at an electric utility, regulatory agency, or legislative office. Two (2) years of progressively responsible experience in regulatory affairs, legislative affairs, or energy policy at an electric utility, regulatory agency, or legislative office.
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Works closely with the Associate Dean for Education, Associate Dean for Equity and Inclusion, Admissions, and Student Affairs, Program/Specialty Directors, Program Administrators, Curriculum, Progression, and Program Evaluation Committees, and faculty to ensure program outcomes and continuous improvement, including collaboration on course offerings, program changes, and student experiences.
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ADARs will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third-party affiliates.
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This Regulatory Affairs Manager - Digital Health Technology will work on-site at our Alameda, CA location in the Diabetes Care Division. This Regulatory Affairs Manager - Digital Health Technology will provide support for the regulatory department to ensure efficient and compliant business processes and environment.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Strong ability to work cross functionally with such functions as Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and applicable third-party affiliates.
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They will play a critical and exciting role in helping the US Medical Affairs organization support current HIV prevention therapies and potentially launch future HIV prevention pipeline products, with a focus on injectable PrEP. The Associate Director will report to the US HIV Prevention Strategy Lead and will work directly with the US and Global teams.
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affairs job Title: principal Company: Parexel
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