Deputy Regulatory Affairs Manager

Job Description

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