Deputy Program Manager RA/ BD (FDA)

• Mar 2022 - Present

MBA Candidate | Dean’s Scholar

• Jan 2020 - May 2022

Project Manager (Clients - FDA I HHS I CDC)

• 2018 - Mar 2022

• Co-ordinated and delivered Panorama, Appian, Exari, Mercado work management training to 150+ people for the FDA resulting in the effective streamlining of the new drug regulatory review process • Led a team of consultants to successfully create and present case studies on time saving potential as part of the CDER Informatics Boot Camp resulting in implementation across the platform for users at the FDA• Managed Training and Communication plans for HHS DCIO (Deputy Chief Information Officer)•Liaise with different teams to obtain the require documentation for regulatory submissions. Develop and maintain knowledge of ICH and FDA regulations and guidance.

Regulatory Affairs Associate (Client- FDA)

• Apr 2016 - Sep 2018

• Assist in preparing briefing package for FDA meetings. • Attend inter and intra-departmental team meetings to discuss about the ad-hoc projects and the timelines. Give regulatory input during project team meetings. • Develop eTMF, eCTD and eCRF templetes based on FDA and ICH guidelines for a drug life cycle tracking application. • Led a team of clinical and regulatory experts in launching the drug life cycle tracking application which is FDA 21 CFR part 11 compliant at the DIA 2016 conference (Philadelphia) and also at the 4th International Clinical Trial Conference Held in San Antonio Texas in September 2017.

Regulatory Affairs Intern

• Jul 2014 - Sep 2014

• Developed SOPs and Regulatory Strategy Documents and Trained in GMP, change controls, Deviations, Quality and Document management systems. • Assist in assembling and reviewing of IND, NDA, CTA and MAA in cooperation with SMEs to assure regulatory compliance. • Archive and maintain all the FDA and EMA correspondences and submissions on EDMS. • Perform QC checks of all the documents to ensure eCTD readiness. • Filing of Initial and Follow up IND safety reports. • Developed SOPs and Regulatory Strategy Documents and Trained in GMP, change controls, Deviations, Quality and Document management systems. • Assist in assembling and reviewing of IND, NDA, CTA and MAA in cooperation with SMEs to assure regulatory compliance. • Archive and maintain all the FDA and EMA correspondences and submissions on EDMS. • Perform QC checks of all the documents to ensure eCTD readiness. • Filing of Initial and Follow up IND safety reports.