1. Prepare dossier section and product information documents for variations in UK/EU Market.
2. Prepare deficiency responses and National phase documents for submission of variations in UK/EU Market
3. Prepare renewal application for product life cycle management.
4. To provide inputs for regulatory strategy and contributing to development programs.
5. Co-ordination with CMC team and other cross functional department for smooth regulatory submissions.
6. Carry out regulatory functions as and when required supporting the regulatory compilations.