Regulatory Affairs professional with extensive global drug development and registration experience. Hands-on experience with expedited drug development pathways (Breakthrough Therapy designation, Fast Track, accelerated approval, priority review, rolling submission, Innovative Licensing and Access Pathway [ILAP]), orphan drug designation, PIP and iPSP/pediatric Written Requests (US pediatric exclusivity achieved). Regulatory lead for successful PCNS Advisory Commitee Meeting. Led the submission of multiple NDA/BLA/MAA submissions (antihypertensive, insomnia, Alzheimer's disease) and major efficacy supplements (anticoagulant, GERD, Alzheimer's disease), with many submitted simultaneously. Experience with the US accelerated approval pathway and confirmatory trials.Led multiple meetings with global Health Authorities with successful outcomes. Experience with managing high-performing Regulatory team and cross functional leadership. Recipient of HBA Rising Star Award 2023. Member of the BIO Pediatrics Committee.Regulatory Affairs Certification (RAC) – US (2007) Regulatory Affairs Certification (RAC) – EU (2008)