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The Regulatory Affairs Specialist will provide regulatory support for the Catalent Cell and Gene Therapy sites. This position will evaluate facility change controls for compliance with applicable change control guidance and will maintain site master files and Type V DMFs. In addition, the Regulatory Affairs Specialist will provide audit support and assist in preparing for group meetings and communications as appropriate.
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In conjunction with the AVP, Medical Affairs NA - Biologics and Market Access, will be the responsible member of the Sun Pharma medical department in regulatory interactions, ISS and expert advisory board meetings, external professional societies, seminars, and conventions.
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We invested in new offices, sector teams and practice groups including higher education; foundations; 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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Mammoth BioSciencesOPPORTUNITYMammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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Supporting the Head of U.S. Government and Regulatory Affairs and Head of the DC Office to develop and execute a Washington, DC public policy strategy with the U.S. Congress, U.S. Administration, and U.S. regulatory agencies.
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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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Working under the Director of the RNA Program and closely with the CEO, you will collaborate with cross-functional teams, including research, manufacturing, product development, clinical development, and regulatory affairs to ensure successful RNA vaccine development.
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Provide worldwide regulatory strategy and oversight to ensure Moderna can describe, and support processes required for commercialization of INT products (i.e., neoantigen selection (next generation sequencing and bioinformatics) as well as related to front end specimen collection.
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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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A minimum of 6-10 years’ experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. The ideal candidate will have experience in chemical and environmental regulatory compliance, packaging regulatio ns, product stewardship and industrial risk management in the medical device or manufacturing industries.
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The Student Affairs portfolio includes but is not limited to, the VPSA Office, Dean of Students Office, Center for Student Leadership and Engagement, Fraternity/Sorority Life, Office of Community and Ethical Standards, Campus Recreation, Office of Advocacy and Success, Student Health and Wellness Services, Campus Reservations and Events, Student Affairs Business Operations, Military and Veteran Engagement, Residential Living and Resident Learning.
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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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The vice chancellor serves as the senior officer responsible for enrollment management, student success, student affairs, international affairs, and their related strategic initiatives, reporting directly to the chancellor with a dotted line to the provost and executive vice chancellor and serving as an active member of the chancellor's cabinet.
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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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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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regulatory affairs jobs Company: Travelnursesource in IA, Germany
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