Deputy Regulatory Affairs Manager

Regulatory Functional:
†Compilation of dossier for ROW market as per the country specific requirements (from Module-1 to Module 5)
†Ensure compliance to county specific regulatory requirements (i.e., Africa, ASEAN, CIA, Gulf, Asia pacific, Latin America)
• Ensure labeling compilation as per the country specific requirements
• Review of DMFs of complex peptide drug substances
• Post approval activity, variation filing (Major and Minor) as per change proposal recommend by the manufacturing site or client
• Experienced with handling drug device combination regulations and understand the requirements for submission in line country specific requirement (Prefilled syringes and disposable pens)
• To assure consistency and adequacy of submissions in line with current regulatory requirements/expectations
• Ensure timely response to the deficiencies received from the agencies
• To communicate & coordinate with different stakeholders within the organization/ third party contract manufacturers to resolve any delay in submissions
• Life cycle management of products to include renewals, reviewing & approving the change controls and ensures product continuity through filing and timely approvals of variations. Support the continuing activities through coordination with various stakeholder
• Approval package compilation and provides support for lunching of the approved product