Sanje A. Goonasekera PhD, PharmD, RPh, RAC (US, Drugs)

- Develop, manage and maintain corporate regulatory Intelligence capabilities, inclusive of global regulatory surveillance - Identify, interpret and disseminate relevant regulatory and competitive intelligence information throughout the organization. - Increase internal awareness, knowledge and regulatory compliance to generate innovative regulatory strategies designed to efficiently manage client portfolios and enable time- and cost- efficient drug development

- Independently managed projects running in parallel, while ensuring timely completion of project deliverables - Acted as the regulatory liaison with FDA on behalf of the organization to facilitate timely and favorable review of regulatory submissions - Worked with cross-functional teams to maintain timelines for regulatory deliverables encompassing Pre-IND and IND activities - Conducted meetings with internal teams, Sponsors, and FDA as needed - Drafted key messaging to be used in preparation of regulatory documents for submission to the FDA - Critically evaluated regulatory documents developed by the internal team, performed document quality control checks in alignment with internal processes - Advised Sponsors on regulations as they apply to Pre-IND and IND activities - Ensured FDA submission were in compliance with applicable regulations and guidance documents, and proactively maintained current knowledge base on existing and emerging regulations, standards, and guidance documents - Precepted fourth-year pharmacy students during their advanced pharmacy practice experiences