Global Regulatory Affairs Labeling Expert
4 weeks ago
This role serves as the Global Regulatory Affairs Labeling Expert to the Global Regulatory Team, providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads. The successful candidate will manage multiple assigned projects of increased complexity, including post-marketing projects and those involving 3rd party development.
Key Responsibilities- Act as point of contact for cross-functional teams on global labeling issues, ensuring compliance with all applicable regulations and guidelines.
- Manage updates to Company Core Data Sheets for assigned products, ensuring implementation of CCDS/labeling agreements with licensing partners.
- Prepare documents for review by labeling teams, leading review processes and ensuring appropriate governance for US, EU, and Company Core documents.
- Research applicable Health Authority labeling regulations for products and filings, managing compliance with internal and external guidelines.
- Bachelor's Degree in a scientific discipline; advanced degree preferred.
- 10+ years pharmaceutical industry experience, with 4+ years direct regulatory affairs experience, including CCDS and US/EU labeling experience.
- Experience with country labeling a plus (outside the US/EU) preferred.
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Regulatory Affairs Labeling Manager
4 weeks ago
Atlanta, Georgia, United States Proclinical Staffing Full timeJob Title: Manager, Regulatory Affairs LabelingProclinical is seeking a remote Manager, Regulatory Affairs Labeling for a global biopharmaceutical company.Key Responsibilities:Lead the development of new labeling content in collaboration with a cross-functional project team.Manage the creation and maintenance of all US product labeling components using...
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Regulatory Affairs Expert
3 weeks ago
Atlanta, Georgia, United States Accordance Search Group Full timeAccordance Search Group is seeking a highly skilled Regulatory Affairs Expert to join our team. As a key member of our regulatory team, you will be responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices, and preparing and submitting regulatory submissions in...
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Regulatory Affairs Expert
4 weeks ago
Atlanta, Georgia, United States Barrington James Full timeRegulatory Affairs Expert - Medical DeviceBarrington James is seeking a highly skilled Regulatory Affairs Expert to join their team. As a key member of the Regulatory team, you will be responsible for developing and executing regulatory strategies for unique medical devices.Key Responsibilities:Develop and execute regulatory strategies for medical...
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Regulatory Affairs Strategist
2 weeks ago
Atlanta, Georgia, United States Accordance Search Group Full timeJob DescriptionAccordance Search Group is seeking a talented Regulatory Affairs Strategist to join our team.The successful candidate will be responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices, and preparing and submitting regulatory submissions in the US,...
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Atlanta, Georgia, United States Kemira Full timeAbout KemiraKemira is a global leader in sustainable chemistry, driving human progress and quality of life through innovative solutions. With a rich history spanning over 100 years, we've established ourselves as a trusted partner in the water-intensive industries. Our mission is to create chemistry with a purpose, better every day.Job SummaryWe're seeking a...
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Regulatory Affairs Strategy Director
4 weeks ago
Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full timeLegacy of InnovationDaiichi Sankyo Group is dedicated to creating innovative pharmaceutical therapies to improve standards of care and address unmet medical needs globally. With over 100 years of scientific expertise and a presence in over 20 countries, Daiichi Sankyo and its 16,000 employees draw upon a rich legacy of innovation and a robust pipeline of...
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Global Labeling Lead
3 weeks ago
Atlanta, Georgia, United States Takeda Pharmaceuticals Full timeAbout the Role:At Takeda Pharmaceuticals, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients...
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Regional Manager Regulatory Affairs
4 weeks ago
Atlanta, Georgia, United States Symmetrio Full timeJob OverviewSymmetrio is seeking a seasoned professional to fill the role of Regional Manager Regulatory Affairs & Quality Americas. This position will oversee the functions and team for the North and South Americas Region, aligning with the department's defined directions and initiatives.Key ResponsibilitiesDrive departmental activities in line with the...
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Regulatory Affairs Specialist II
3 weeks ago
Atlanta, Georgia, United States Abbott Laboratories Full timeAbbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...
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Global Marketing TK2D Lead
3 weeks ago
Atlanta, Georgia, United States UCB Full timeJob DescriptionAbout the RoleThe Global Marketing Lead, TK2D, will work with a cross-functional and regional partnership that delivers final preparation for a world-class launch (EU, US, Intercontinental) of an ultra-rare TK2D disease including the readiness of a ultra model Global to Local.About the TeamThe Global Marketing Lead, TK2D, will be part of the...
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Interdisciplinary Scientist
4 weeks ago
Atlanta, Georgia, United States Food and Drug Administration Full timeJob SummaryThis Interdisciplinary Scientist position is located in the Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), Office of Human and Animal Food Lab Operations (OHAFLO). The incumbent serves as an analytical instrumentation specialist within an ORS Laboratory who is recognized as the expert, technical authority and resource...
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Regulatory Licensing Director
4 weeks ago
Atlanta, Georgia, United States Unity Works Talent Full timeJob Summary:The Director, Regulatory Licensing is responsible for ensuring compliance with government regulations and licensing requirements for all business units and divisions within the organization. This role involves coordinating and completing government and regulatory filings, working closely with senior leadership, and leading key projects related to...
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Associate Director of Local Government Affairs
3 weeks ago
Atlanta, Georgia, United States Emory HealthcareEmory University Full timeJob SummaryThe Associate Director of Local Government Affairs coordinates and administers a robust advocacy program at the local government level for city and county municipalities in which Emory has a presence. This role requires a strong understanding of legislative, budget, and regulatory issues, as well as excellent communication and project management...
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Regulatory Compliance Specialist
4 weeks ago
Atlanta, Georgia, United States CorDx Full timeJob OverviewCorDx, a leading biotechnology company, is seeking a highly skilled Regulatory Coordinator to support our regulatory compliance efforts. In this role, you will play a critical part in ensuring the company's products meet regulatory requirements and are approved for market release.Key ResponsibilitiesAssist in the preparation, submission, and...
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Atlanta, Georgia, United States AIG Full timeAbout the RoleWe are seeking an experienced Associate General Counsel to join our Global Legal, Compliance, Regulatory and Government Affairs (GLCR) department. As a key member of our team, you will play a critical role in providing high-quality advisory and transactional support to our organization.Key ResponsibilitiesDraft, structure, and negotiate complex...
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Regulatory Counsel
4 weeks ago
Atlanta, Georgia, United States Boston Consulting Group Full timeAbout the RoleWe are seeking a highly skilled Regulatory Counsel to join our Global Legal Team at Boston Consulting Group. As a key member of our team, you will play a critical role in driving impact and progress across several important dimensions.Key ResponsibilitiesDrive Regulatory Change Initiatives: Identify, manage, and drive regulatory compliance...
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Associate Director of Local Government Affairs
4 weeks ago
Atlanta, Georgia, United States Emory HealthcareEmory University Full timeJob SummaryWe are seeking a highly skilled Associate Director of Local Government Affairs to join our team at Emory University. This role will be responsible for coordinating and administering a robust advocacy program at the local government level for city and county municipalities in which Emory has a presence.The successful candidate will have a strong...
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Software Development Expert
3 weeks ago
Atlanta, Georgia, United States Saxon Global Full timeJob Title: Software Development ExpertJob Summary:Saxon Global is seeking a skilled Software Development Expert to join our team. As a key member of our agile team, you will be responsible for designing, implementing, and revising software applications. Your expertise in Java technology stack and experience with client-side/front-end development will be...
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Privacy Counsel
3 weeks ago
Atlanta, Georgia, United States Taboola Full timeJob Title: Privacy CounselTaboola is seeking a highly skilled Privacy Counsel to join our global Legal team. As a Privacy Counsel, you will be responsible for maintaining and developing our privacy program, advising on best practices, and ensuring compliance with complex and ever-changing privacy laws and regulatory requirements.Key Responsibilities:Provide...
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Chief Counsel for Health Affairs
4 weeks ago
Atlanta, Georgia, United States ACC - Association of Corporate Counsel Full timeJob Title: Chief Counsel for Health AffairsEmory University's Office of the General Counsel is seeking a highly experienced and skilled Chief Counsel for Health Affairs to oversee all legal matters for Emory Healthcare and serve as the primary legal advisor to Emory Healthcare's CEO, senior management team, Board of Directors, and more than 490 outpatient...