Branch Chief
CurrentAs a Branch Chief, I lead and manage 17 direct reports, including analysts and pharmacists performing assessment of generic drug submissions for user fees and other regulatory mandates under Generic Drug User Fee Amendments (GDUFA). I supervise overall activities related to annual setting of GDUFA user fees and conduct forecasting of annual fees and drafting of federal register notice. Utilizing industry knowledge, I manage user fee regulatory policies development pertaining to 505 (j) submissions and inform users regarding regulatory changes that might impact such policies. I monitor execution of new systems and processes supporting new law and regulation. I adeptly negotiate with regulated industry, trade associations, and management staff during the implementation of FDA’s policy positions. I take initiatives and formulate SOPs to guarantee delivery of operational program support. Key Contributions:• Produced documents and strategic communications for stakeholders highlighting policy and statutory matters.• Defined and created guidelines, regulations, and legislations in collaboration with cross-disciplinary working to enhance FDA’s mission of advancing and protecting public health.• Devised and executed mitigating strategies to identify and overcome potential issues as well as established relations with key stakeholders to expedite access to affordable generic medicines to the American public.• Leveraged key industry knowledge while creating performance metrics and provided executive leadership to staff through coaching and growth opportunities.• Delivered active functional support to office director regarding workflow optimization, staff performance appraisals, and new employees training and development initiatives.• Played a key role in authoring statutory language to improve or add to GDUFA’s user fee objectives at every reauthorization year.
