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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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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.
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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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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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Vice Provost for Student Affairs, Stanford, California, United States. Vice Provost for Student Affairs, Stanford, California, United States. Proactively collaborate and establish relationships with the wider community of graduate career and professional development at Stanford (including academic units, student services departments, other campus career offices, and key personnel) to support the career development of PhD students and postdocs.
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Under the supervision of a Global Virology Regulatory Affairs liaison, the intern will work with various team members in the Gilead Foster City team to support regulatory submissions in the United States and potentially other countries for marketed and investigational products.
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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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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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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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Review Engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance. Prepare regulatory strategies/plans and ensure compliance with worldwide requirements.
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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Amgen in Belmont, CA
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