A Director, Global Regulatory Affairs Labeling job in Basking Ridge, New Jersey is available courtesy of Adecco Medical and Science. The company has a large and growing pipeline within oncology, cardiovascular, and other therapeutic areas. This individual will head the development and approval of labeling, and oversee every aspect of regulatory labeling strategy and objectives.
Director, Global Regulatory Affairs Labeling responsibilities include:
• Manage senior level relationships among stakeholders, to help ensure labeling accuracy, quality, and compliance with all regulations.
• Prepare USPI and Core Data Sheets, establish processes for label changes ensuring compliance, and head label review meetings to optimize processes.
• Coordinate and help lead cross-functional teams, especially within pharmacovigilance, supply chain, and legal groups, to ensure accurate and timely deliverables.
• Create best practices within applicable processes and systems, including but limited to SOPs, labeling agreement templates, and process improvements to planning, tracking, and label coordination with logistics.
• Advanced Scientist Degree, preferably Ph.D. or Pharm.D.
• 15 to 25 years of experience in pharmaceutical experience
• 8 to 15 years within regulatory affairs, with direct labeling experience
• Relevant experience within both domestic and international markets
If you are interested in this Director, Global Regulatory Affairs Labeling job in Basking Ridge, New Jersey then please click APPLY NOW. For other opportunities available at Medical and Science go to www.adeccousa.com. If you have questions about the position please contact Jonathon Blauvelt at firstname.lastname@example.org.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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