Harshith Anusuyadevi Shivamalavaiah

Regulatory Affairs Assistant @Lexon

Redditch, GB

Preparing artwork mock-ups for PILs and outer packaging using QuarkXPress, NiceLabel, and TVT, ensuring alignment with regulatory standards and MHRA requirements for consistency and compliance.• Secured grants for over 100 product variations, including updates to PILs, label changes, transitions from re-carton to relabelling options, and others, with a 99% approval rate without Requests for Further Information (RFIs).• Preparing and submitting initial applications, with over 20 already submitted to date; 9 applications granted (3 without RFIs), with the remaining currently under review.• Proactively monitoring the MHRA portal (Intralinks) to follow up on application statuses, RFIs, and product updates, contributing to efficient workflow management.• Creating and maintaining Master Reference Files (MRFs) to support initial application grants; over 5 new MRFs have been released for production to date.• Managing PI Trademark issues through direct negotiation with TM holders, clearing the majority of cases, with remaining products under review for release from quarantine.• Participated in MHRA and BAEPD joint seminars on high-quality initial applications, actively raising queries and obtaining regulatory clarifications.• Collaborating cross-functionally with buying, printing, packaging, and quality assurance teams to streamline regulatory workflows, improve dossier accuracy, and support timely market release of products.

Bharathi College of Pharmacy

Doctor of Pharmacy - PharmD, Pharmacy

Kingston University

Master of Science - MS, Pharmaceutical Sciences with Drug discovery and development