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The Senior Configuration Manager position is part of the Acquisition and Property Management (APM) Space Management Support System (SMSS) team within the Acquisition and Property Management (APM) portfolio in support of the US Department of Veterans Affairs, Consolidated Corporate Support Services (CCSS) program.
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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Senior Regulatory Affairs Specialist, Redwood City, CA - Develop strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate approval with global regulatory agencies.
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Conduct in-depth investigations that include thorough reviews of transactional activity, internal KYC records, and open source research and file Suspicious Activity Reports (SARs) in accordance with regulatory reporting requirements.
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
$295,290 - $382,140ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Vice Provost for Student Affairs, Stanford, California, United States. The Assistant Director of Career Coaching and Education assists PhD students and postdocs in identifying and pursuing diverse professional pathways as they advance their career journeys at Stanford and beyond.
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Work with product, regulatory, privacy, security, engineering, operations, sales, and marketing teams to develop strategy for various market segments and verticals in U.S. and abroad (including financial services, heathcare, SLED, and public sector.
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Director, CMC Regulatory Affairs – Biologics. Head of CMC Regulatory Affairs – Small Molecules. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
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Collaborate seamlessly and coordinate efforts with Stanford University, School of Medicine, and Stanford Hospital on Government relations affairs. The Senior Vice President & Chief Government Relations Officer (SVP & CGRO) provides strategic oversight and is responsible for government affairs strategies that advances SMCH's mission and goals at local, regional, state, and federal levels.
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Reporting to the Clinical Research Manager of Blood & Marrow Transplantation and Cell Therapy (BMT-CT), the Clinical Research Coordinator Associate will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to to manage data, enroll and follow patients on trial, and assist with regulatory and financial requirements of the trials.
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This role will include (i) drafting and negotiating various contracts and other legal documents in support of the Human Resources, Finance, Public Affairs, Government Affairs & Policy and Legal organizations (including the General Counsel’s Office) ; (ii) being the primary point of contact on legal contract issues for one or more client groups; and (iii) working closely with the Corporate Contracts Legal team to support other projects and work as needed.
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Quality Review is an exceptional team of highly skilled professionals within the Global Regulatory Operations (GRO) department which resides in the Regulatory Affairs organization.
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Gilead Sciences is seeking an attorney to join our growing Corporate Contracts Legal Team. We are looking for an attorney with. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
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The ideal candidate must have experience in securities enforcement, white-collar defense, regulatory investigations, and compliance matters. Handle securities enforcement matters, white-collar defense, regulatory investigations, and compliance issues.
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We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago
regulatory affairs jobs Title: regulatory affairs assistant Company: Abbott Laboratories in Belmont, CA
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