Sruthi Sunkari Pharm

WORK HISTORY

EDUCATION

ABOUT SRUTHI SUNKARI PHARM

Regulatory Affairs professional with 6+ years of experience across biosimilars, global lifecycle management, and strategic regulatory support for multinational pharmaceutical organizations.My career began in biosimilar regulatory filings at Viatris, where I gained strong expertise in dossier compilation, variation management, and global submission strategy across emerging markets. This foundation strengthened my technical understanding of eCTD structures, CMC documentation, and regulatory intelligence.Currently, I support global regulatory activities for Gilead projects through Freyr Solutions, contributing to lifecycle management, regulatory coordination, and cross-functional alignment across regions. Working within a global matrix environment has strengthened my ability to manage timelines, implementation strategies, and stakeholder communication effectively.Alongside my regulatory background, I hold:• MSc in Regulatory Toxicology• MSc in International Management (UK)• Membership with The Organisation for Professionals in Regulatory Affairs (TOPRA)This blend of regulatory science and international business management enables me to approach regulatory strategy not only from a compliance perspective but also from a commercial and lifecycle planning viewpoint.I am particularly interested in:• Global regulatory strategy• European and UK lifecycle management• Labelling & post-approval variations• Regulatory intelligence & implementation alignmentMy long-term objective is to contribute to a UK/EU-based pharmaceutical organisation in a strategic regulatory role where I can support global submissions, lifecycle optimisation, and cross-regional regulatory alignment.I value structured processes, proactive communication, and continuous professional development, and I am committed to building a long-term career within the UK regulatory landscape.