• Preparation of Regulatory Affairs documentation for submission to Regulatory Agencies predominantly into US and EU.
• Review of CMC (BPRs, BMRs, PDRs, specifications, dissolution data, validation protocols, etc) and Clinical Study documents (protocol, data, report)
• Gap analysis of documents based on Agency requirements
• Life cycle management of approved products
• eCTD publishing
• Responding to deficiencies/queries raised by Regulatory Agencies
• Assist in the development of regulatory strategies
• Maintain knowledge and understand SOPs, Client SOPs/directives and current regulatory guidelines as applicable to services provided
• Coordination and communication with project teams, clients, internal departments and Regulatory bodies at global level for all operational procedures to support global projects
• On-site customer support, development and trouble shooting