Arvind Kaundal

Roles & Responsibility

Responsible for the end-to-end management of regulatory dossier activities for UK/EU markets, including compilation, review, and submission of Initial MA applications and RFI responses per MHRA and EMA guidelines. Expertise in preparation and assessment of Administrative, CMC (m1-m3), and plant-related documents, ensuring compliance with CMC requirements such as batch records, specifications, stability, validation, and impurity risk assessments. Skilled in product information development (SmPC, PIL, Label) aligned with EMA QRD and UK standards, artwork review, and post-approval variation submissions. Proficient in CEP tracking and maintenance of regulatory compliance throughout product lifecycle.