Jill Powers Email & Phone Number

Southwest Florida

• Interacted with the FDA (and other international regulatory agencies, as needed) on a proactive, independent, and frequent basis. Communicated company views to Regulators and maintained effective, professional relationships with Regulatory agency officials.• Gave direction for assigned programs by planning and coordinating all aspects of regulatory submissions and responses, and regulatory management of products over their life-cycle.• Represented Regulatory Affairs on internal project teams; provided advice to project teams and line departments on regulatory requirements, guidelines and strategy.• Worked collaboratively with project team members and line departments to facilitate efficient submissions and rapid approvals of regulatory applications.• Worked with Regulatory Affairs colleagues in Regulatory CMC, Regulatory Operations, etc., to ensure integrated, well-coordinated approaches to planning regulatory submissions and responses, and developing solutions to regulatory issues.• Managed the timely preparation and submission of INDs, NDAs, BLAs (and corresponding international registration packages), amendments/supplements/variations to these applications, and responses to regulatory agency questions.• Oversight of vendors and contractors for development projects and ROW expansion.• Accountable for regulatory strategy and regulatory development plans for assigned products.

• Provided strategic regulatory guidance to management and project teams with respect to meeting FDA compliance requirements and identification of regulatory risk • Regulatory Affairs representative on Copy Review Committee for review and approval of labeling, sales training, promotional and advertising pieces• Served as primary interface with the FDA for IND, NDA, and Orphan Drug related written and verbal communication • Used working knowledge of core regulatory processes: discovery, development, manufacturing and marketing to achieve business objectives• Advisory Committee preparation • Provided training, guidance and performance reviews to Senior Regulatory Associates and Regulatory Assistants• Conducted regulatory intelligence and due diligence

• Daily management of Regulatory Affairs Department • FDA liaison for Non-US based clients• Project management, submission and maintenance of NDAs, INDs and IDEs• Submission of safety reports• Wrote and cross-referenced submission documentation• Coordinated submission timelines between Data Management, Medical Writing, Quality Assurance and Regulatory Affairs• QC of statistical tables and listings• Wrote, reviewed and revised Regulatory department SOPs

Education record

Bachelor Of Science, Biology