Director Regulatory Affairs

VirtualVocations
Memphis, Tennessee, United States
Full-time
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A company is looking for a Director, Regulatory Affairs.Key Responsibilities : Focus on clinical regulatory filings and providing strategic and operational leadership on project teamsContribute to IND / CTA and BLA submissions activities for products in developmentDevelop regulatory strategies for assigned programs and communicate with regulatory agenciesRequired Qualifications : 10 years of pharmaceutical industry experience, with at least 5 years in regulatory affairsM.

D., Ph.D., or Pharm. D. degree or equivalent work experienceStrong background in Regulatory Affairs with successful interactions with Regulatory AgenciesKnowledge of global regulations, particularly US FDA regulationsExperience in managing regulatory activities associated with drug development programs

3 days ago
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