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Ability to create procedures to interpret and align with regulatory policies, while enabling investigators perform appropriate level of due diligence. Certified Global Sanctions Specialist certification is a plus.
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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.
$165,200 - $333,800 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Practical experience in the pharmaceutical or biotech industry of at least five years in at least one major area of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs.
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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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Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Provide CMC regulatory review for clinical protocols and investigator brochures, etc.
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The School is seeking a full-time Director of Instruction and Academic Affairs/Academic Coordinator (AC) to provide academic administration for all academic programs, including our accredited Master's in Social Work (MSW) professional degree program, undergraduate major in Social Welfare, doctoral degree program, and graduate certificate programs.
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The ideal candidate has a strong financial regulatory background, either from a federal regulatory agency, or as in-house counsel or outside counsel to a broker-dealer and/or investment adviser.
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In-depth knowledge of CMC regulatory requirements for Advanced Therapy Medicinal Products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
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Works with Manager of Legislative Affairs to draft, develop and manage the legislative process for all required department-initiated legislation for Grants, Contracts, Real Estate and other legislative needs, and may directly manage at least one of these portfolios.
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Work closely with the Head of Scientific Affairs & Strategic Partnerships and Scientific Affairs team to produce rapid, thoughtful responses to content-related requests from across Pfizer Oncology (CSO, Medical strategy, BoD, Investor Relations, colleagues, etc.
$191,300 - $318,800 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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GPS also administers the International Studies Program, a fast-growing interdisciplinary program with over 1700 declared undergraduate majors, that offers a rigorous curriculum for undergraduate students interested in international affairs.
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Reporting directly to the head of medical affairs, the Senior Director will play a pivotal role in leading the development and execution of strategies to generate and leverage real-world evidence to support the launch, development, market access, and commercialization of Aerovate's novel cardiopulmonary therapy.
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JOB ID: R-184281 LOCATION: US - California - San Francisco WORK LOCATION TYPE: Field Worker DATE POSTED: Mar. 12, 2024 CATEGORY: Medical Affairs SALARY RANGE: 162,414.00 USD - 185,108.00 USD. Two years of proven experience in Medical Affairs at a biotech or pharmaceutical company.
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UC Berkeley's Office of Communications and Public Affairs leads communications for the most elite public higher education institution in the world, conveying the quality, diversity, vitality, preeminence and dedication to service of UC Berkeley.
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Our Regulatory Affairs team is seeking a highly motivated Regulatory Operations Manager. Reporting to the Senior Director of Regulatory Operations, you will be responsible for assembling, formatting, and publishing regulatory dossiers (e.g., IND, CTA, BLA, MAA) for global registration and lifecycle management submissions (e.g., supplements, amendments, variations) to meet corporate objectives for both ongoing business and new product development.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Amgen in Oakland, CA
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