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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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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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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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Invenergy is seeking a knowledgeable and proactive Senior Manager for Government Affairs to support our growing Public Affairs team. As a Senior Manager, California Government Affairs, this individual will focus on Invenergy’s California government affairs activities for all aspects of Invenergy’s growing business.
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Our work depends on Regulatory Affairs Manager joining our team to contribute to PKI and Identity Management policy development, technical liaison and advisor. Seize your opportunity to make a personal impact as a Regulatory Affairs Manager supporting a PKI Government High Value Asset Mission Essential Function program.
$155,934 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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All fellows will complete a fellowship project for presentation to the Regulatory Affairs department and/or at a key conference/congress. The fellow will report to the fellowship track manager within the Regulatory Affairs – Therapeutic Area team throughout the one-year program.
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Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards. Deep understanding of CDISC standards and regulatory submission requirements.
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This position is hybrid, and based in Santa Monica, CA and reports to the Executive Director, CMC Regulatory Affairs. The AD CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies.
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The Vice President of Government Affairs will lead Veralto's government affairs strategy and operations globally, with overall responsibility for managing legislative, regulatory, political, and reputational risks while promoting growth opportunities.
$350,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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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.
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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. In this role, a typical day might include:The Regulatory Intelligence Manager performs proactive global monitoring and surveillance of changes in the regulatory landscape focused on the drug development lifecycle, i.e., preclinical through commercialization, as well as disseminate relevant regulatory intelligence information to Regeneron stakeholders.
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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams.
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Work closely with Global Patient Safety and Risk Management (GPSRM), Clinical Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies, EMR/claims data, and RWE. The Senior Director, Epidemiology reports directly to the Senior Vice President, Data Science, Statistics, and Epidemiology.
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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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Reporting to the Senior Director for Federal Affairs, the Senior Manager will assist with research and direct lobbying to support AIA’s federal legislative agenda. Bachelor’s degree in political science or related field with 4-6 years of lobbying or general government affairs experience is required; Campaign and/or Grassroots/Grasstops experience is desired but not required.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Katalyst Healthcares Life Sciences
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