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