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JOB DESCRIPTION Job TitleSr. Regulatory Affairs Specialist-CT/AMIJob DescriptionThe Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy.
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As our Regulatory Affairs Manager, you will play a crucial role in our product development team by ensuring that all new and existing products comply with regulatory standards in the United.
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Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies.
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Typical Minimum Experience 13+ years of relevant Quality Assurance and Regulatory Affairs experience 5+ years of management experience 4-year degree in business or related field or equivalent experience Advanced degree a plus (MBA, MS) Must be able to travel up to 30-40% Critical Skills 5 + years’ experience working within Quality Assurance in a government regulated environment Accreditation experience with ISO Standards or regulatory agencies (DEA, FDA, etc.
$142,200 - $237,000 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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We are seeking a global Executive Director, Regulatory Affairs, Gene Therapy (level determined by candidate experience) reporting into the SVP Clinical Operations who will serve as the strategic lead representing regulatory affairs expertise managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc.
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Regulatory and QA Specialist Our client is a highly regarded manufacturer of flavors and essential oils. Responsibilities Prepare regulatory documentation for flavors and essential oil products - SDS, Allergen statement, Natural status, GMO, Prop 65, flavor product Ingredient listing, etc.
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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 Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Under the direction of the Manager, Regulatory Affairs assist in preparing the Plan for regulatory audits. Under the direction of the Manager, Regulatory Affairs, the Analyst I - Regulatory Affairs (Policy & Communications) has a general knowledge of and performs key centralized regulatory activities of moderate difficulty for the Compliance Department.
$30.72 - $39.94 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA. Up to 20% domestic travel required.
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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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ABOUT THE ROLE: The California chapter of CAIR (CAIR-CA) is looking for a passionate and talented individual to fill the Legislative & Government Affairs Manager position. Experience in a nonprofit advocacy organization, trade association, state legislature or Congress, state, or federal agency, working in a corporate government affairs office or trade association.
$72,000 - $90,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Regulatory Affairs team is highly cross-functional and work will center on collaborating with internal scientific, business and operational teams to address compliance needs of our novel probiotics and dietary supplements.
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The Director of Risk Management and Regulatory Affairs (Patient Safety Officer/Privacy Officer) serves as an accessible resource to the hospital and community on risk management and regulatory issues.
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs.
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Title: manager regulatory affairs Company: Hikma
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