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Minimum 5 years in Regulatory Affairs within any of the following industries: pet food, food, OTC drugs, medical devices or pharmaceuticals; Create and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality, Marketing, Legal, New Product Innovation, Science & Technology, Professional Veterinary Affairs, Supply Chain, and others to achieve the synergy needed to effectively work as a team and promote the business.
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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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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred) Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA) A broad knowledge of development and life-cycle management is preferred.
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Frequent contacts Executive and Legislative branch staff and officials External associations and coalition partners AIA national volunteer leadership and staff AIA state and local components AIA Government Advocacy Committee ArchiPAC Steering Committee Qualifications Federally registered lobbyist High-level understanding of how to successfully lobby Congress and the executive branch, including no less than 4-6 years’ experience in working to advance legislative and regulatory proposals.
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Job Title: Quality Management System (QMS) / Regulatory Affairs (RA) Engineer. Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the site's quality goals and quality metrics.
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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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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 position will have responsibility for overseeing and ensuring the scientific success of epidemiologic and other studies related to maternal RSV by working with other members of the Scientific Affairs team, Pfizer country medical teams, and colleagues in Global Medical Affairs, Vaccine Research and Development, Regulatory, Commercial, Public Affairs, and Health Economics and Outcomes Research.
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This position is based in our Princeton, NJ office with onsite presence 60% of the time and reports to the Head of Regulatory Affairs. Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred.
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Work collaboratively with the Associate Dean of Education & Academic Affairs and with the Associate Dean of Clinical Affairs to ensure that the NEOMED Dental Clinic is in compliance with Commission of Dental Accreditation (CODA) standards.
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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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Work closely with the Deputy Commissioner of Policy and Public Affairs and the Press Secretary in service of the goal that the agency is communicating externally to all our constituents, including through the procuring of interpretation services.
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Counsel and advise the BU in areas of product safety (including TSCA, FIFRA, FDA, OSHA Hazard Communication, Hazardous Materials Transportation), product regulatory affairs, product stewardship, and product risk management as such areas may impact the research, development, manufacture, marketing, sale, handling, transportation and advertising of the BU(s) products.
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The Global Public Policy team's work spans a broad and diverse range of functions and workstreams, including government affairs and government relations; policy, product, and issue area expertise; risk and crisis management and mitigation; outreach, coalitions, and partnerships; and philanthropy.
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The Federal Regulatory Affairs Manager will collaborate closely with the North America Team Leader and business-lead Vice Presidents to develop regulatory strategies to ensure registrations are obtained and maintained to meet business objectives and timelines.
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regulatory affairs jobs Company: Milford Center Milford De in Vienna, West Virginia
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