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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. 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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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD.Demonstrated organizational leadership skills at both functional and enterprise levels.
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HJF is seeking a Regulatory Affairs Specialist to assist in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA.
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The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products.
$235,000 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Track animal care and sustainability developments in legislative/regulatory affairs across species (cage-free, animal medication/housing, etc.) Work alongside Coca-Cola corporate teams to identify issues, legislative, regulatory, and lobbying opportunities.
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Provide practical and timely legal guidance on issues related to clinical, biometric, medical affairs, patient advocacy, regulatory affairs, pharmacovigilance, program and asset management, commercial development, pricing & reimbursement, sales, marketing, market access, patient services, and government affairs.
$306,700 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Regulatory Affairs Manager 72224 FullTime - Remote/New Britain, CT Imagine working for a company that knows their employees are the key to its success, a company that provides exceptional results while being environmentally conscious and ahead of the curve in research and development; MicroCare LLC is that company.
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The position will support the Legislative Affairs team, which is part of DFC's The Office of External Affairs (OEA). OEA is the public affairs, communications, and Congressional and interagency liaison arm of DFC.
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Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site. Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
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Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political & regulatory affairs staff to translate regulatory and market issues into business impacts and opportunities to benefit the position of Pattern's new and core business interests in MISO and other priority markets.
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7+ years of experience working with the state Legislature, the Executive Branch, municipal government officials, government relations, public policy, advocacy, government affairs, or campaigns. The Vice President, State Government Affairs will be part of the UHG External Affairs organization, responsible for working with colleagues across External Affairs and the Company to develop and implement strategies on the company's declared state government advocacy, growth, relationship and reputational priorities and overall business advancement initiatives with key state policymakers.
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Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
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The Manager CMC Regulatory Affairs is responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all Regulatory CMC technical writing objectives are met for the innovative pipeline of early and late-stage T cell therapies.
$139,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Guides, directs and evaluates (1) Associate General Counsel, (3) Lease Administration Department (1) Senior Paralegals and, (2) Scientific & Regulatory Affairs Department. Provide guidance to Scientific and Regulatory Affairs on regulatory issues related to both product and procedures, including label safety, use of third party literature, and training documentation.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Gpac
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