Betsy Joseph Email and Phone Number

Global Program Regulatory Director, Oncology

Oncology Regulatory Affairs, Global Drug Development

Regulatory StrategyLead team in compilation of submissions (IND annual report, NDA annual report, DSUR, PADER, Investigational Brochure). Assist in meeting preparation for FDA meetings, including providing guidance in authoring briefing packages. Work on teams to submit NDAs by providing guidance for authoring major documents, including Summary of Clinical Efficacy and Summary of Clinical Safety, for drafting labels, and for submission of proprietary names. Support preparation for Advisory Committee meeting, including providing regulatory strategy in authoring briefing package, drafting presentation slides, creating advisory committee member profiles, and meeting with external experts to discuss strategy. Attend face-to-face and teleconference meetings with FDA. Support team in responding to information requests from FDA. Conduct regulatory assessment of products for potential in-licensing and provide findings and recommendation to department head. Regulatory Advertising and PromotionConduct regulatory review of promotional pieces. Work on integration and launch of newly acquired products. Provide guidance based on FDA guidances and regulations to team for concept discussions. Review materials for submission to OPDP for advisory comments. Summarize recent Notice of Violation letters and disseminate to key team members.