Khyati Desai

• Active involvement in the labeling negotiations and approval of MS product in the US. • Supported the development of 120-day Safety Update Report • Responsible for maintaining the USPI and driving all labeling changes for marketed product. • FDA point of contact for pipeline development and marketed products. • Provided global regulatory strategy (including US, EU, Japan) for products in active development. • Coordinated and prepared IND/CTA packages by ensuring compliance with regulations. • Managed agency questions/information requests by collaborating with cross-functional team & developing strategies for timely submissions. • Successfully managed and submitted reports including Development Safety Update Report (DSUR), Investigators Reports, Investigators Brochure (IB), amendments, protocols, PBRERs and IMPD updates. • Collaborated with a partner company to transfer a product and ensure successful close out of trial. • Submitted application to FDA for the withdrawal of an IND. • Reviewed technical and clinical documentation and recommended changes for regulatory compliance. • Researched regulatory information and provided the team with guidance and direction. • Tracked & maintained regulatory documents on Sharepoint, DOMASYS, IRIS & Livelink databases.

• Collect, supervise and maintain regulatory documents from clinical investigative sites • Review documents for compliance with regulations throughout the trial lifecycle, from initiation to closeout • Support clinical operations in resolving regulatory queries from sites and sponsors • Prepare study teams for sponsor audit/inspections by conducting document analysis

• Active involvement in the process of creating target label claims for influenza, RA & Asthma products • Provided precedent searches & comparison matrices of USPIs, EU SmPCs/PIL, other labeling documents • Drafted EU-SmPC response documents for comments obtained from the Rapporteurs, QRD & CHMP • Researched and presented new regulations, statutes, standards & guidance to the medical & labeling team

• Responsible for catering quality of service to 30+ clients including AstraZeneca, Novo Nordisk, Allergan, etc. • Lead a cross-functional customer service team for synthesizing insights to help clients develop strategies • Conducted qualitative as well as quantitative analysis and presented action-oriented results to the board

• Collated perceptions of oncologists while prescribing Mabthera (La Roche) &/or Reditux across 5 major cities in India • Performed competitive intelligence & furnished recommendations for brand planning and marketing

Pooled 100 doctors across India to carry out a deep dive analysis of the brand Omez and played a strategic role to enhance market capitalization by deriving robust marketing strategies