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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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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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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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The Wounded Warrior Project (WWP) Government Affairs Deputy Director assists in the development and implementation of WWP’s public policy strategy to advance its legislative, regulatory, and advocacy priorities.
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We are now looking for a Regulatory Data Office (RDO) Analytics and Reporting Senior Developer to join us in Global Regulatory Operations (GRO) within Regulatory Affairs. The jobholder will be a member of the RDO Analytics and Reporting group, which is specifically tasked with providing analytical and reporting services in support of the Regulatory Affairs business.
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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
$284,375 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In this newly created role, the Senior Manager, Public Policy, EMEA – EU and Regulatory Affairs will be responsible for developing, implementing, and reporting on the company’s public affairs program at the European Union (EU) level and on regulatory topics that impact the business across major markets (e.g. transpositions of EU directives across member states.
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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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We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
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The Army public affairs specialist participates in and assists with the supervision and administration of Army public affairs programs primarily through news releases, newspaper articles, Web-based material and photographs for use in military and civilian news media.
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Policy Advocacy: Monitor regulatory developments and policy initiatives, coordinate with the Regulatory Affairs Specialist, represent the company's interests through proactive engagement, and assist with analysis and drafting papers.
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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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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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Londoneconomics.com. Current Needs:LEI is currently seeking an experienced Executive Assistant/Proposal Writer and Public Affairs Specialist in our Toronto, ON, office. How to apply:Please send your CV and a writing sample (not more than 5 pages) to careers@londoneconomics.com, indicating in the subject line that you are applying for the 2024 Executive Assistant/Proposal Writing and Public Affairs Specialist position in Toronto.
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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
$315,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
regulatory affairs jobs Title: regulatory affairs specialist Company: Kelly
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