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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase I-V clinical trial investigator site files to the Veeva SiteVault platform.
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Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
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The analyst works independently, under the direction of the Regulatory Affairs Manager, to review cooperative and industry-sponsored protocols, revise local informed consents (ICFs), and submit review packets (protocols, ICFs, and other required documents) to the UCSF IRB and external IRBs.
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Learn more at Global Regulatory Affairs business technology team is focused on providing leading-edge technology solutions to help drive J&J Innovative Medicine s Global Regulatory Affairs organization, we are currently seeking an IT Senior Manager, Technical Product Manager, Regulatory Excellence.
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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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Minimum 5 years in Regulatory Affairs within any of the following industries: pet food, food, OTC drugs, medical devices or pharmaceuticals; Create and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality, Marketing, Legal, New Product Innovation, Science & Technology, Professional Veterinary Affairs, Supply Chain, and others to achieve the synergy needed to effectively work as a team and promote the business.
$128,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Minimum of 10 years of experience in CMC regulatory affairs within the biotechnology or pharmaceutical industry. We are seeking a highly experienced and strategic CMC Regulatory Affairs professional to join our growing team.
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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function’s Executive Office.
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Cititec Talent has partnered with a boutique commodity trading company who looking to bring a Regulatory Reporting Specialist into the business to lead their regulatory reporting consolidation efforts, as they streamline their regulatory reporting solutions for Dodd-Frank and EMIR compliance.
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This role leads the Optum Legal, Compliance and Regulatory Affairs (LCRA) Executive Council and is a critical member of the UHG LCRA senior leadership team. This Executive Leadership Team (ELT) role reports to the UnitedHealth Group (UHG) Chief Legal Officer and the Optum Chief Executive Officer, provides thought and practical leadership, and is accountable for legal and regulatory affairs teams, programs, and activities across the Optum businesses.
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3) Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
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Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Time in grade: Current federal employees applying for a promotion opportunity must meet time-in-grade (TIG) requirement of 52 weeks for service at the next lower grade level in the normal line of progression for the position being filled.
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The Principal Scientist provides regional scientific and regulatory expertise and leverages scientific networks to enable the development and execution of Mars Wrigley (MW) Scientific and Regulatory Affairs (SRA) strategy.
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The incumbent will serve as Public Affairs Specialist on the SPAO staff working closely with state NRCS leadership, the State Outreach Coordinator, Program Managers, Field Office staffs, Conservation Partners, local congressional representatives and others.
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regulatory affairs specialist full time jobs Company: 3m
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