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Associate Director Regulatory Project Management

VirtualVocations
Durham, North Carolina, United States
Full-time

A company is looking for an Associate Director, Global Regulatory Project Management and Strategic Planning - GI.Key ResponsibilitiesPartner with the Global Regulatory Lead to establish and maintain global regulatory project plansLead cross-functional project submission working groups to ensure successful regulatory submissionsProvide regulatory operational support and oversight for assigned programs, ensuring timely deliverablesRequired QualificationsBachelor's degree required;

emphasis in Science preferred, advanced degree preferredMinimum of 8 years related experience, with at least 4 years in Global Regulatory AffairsExperience with late-stage filings is highly preferredSignificant experience in global drug development regulations and regulatory submissionsAt least two major eCTD registrations and several minor filing experiences in the USA or other jurisdictions

5 days ago
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