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 requirementsReview of DMFs of complex peptide drug substancesPost approval activity, variation filing (Major and Minor) as per change proposal recommend by the manufacturing site or clientExperienced 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/expectationsEnsure timely response to the deficiencies received from the agenciesTo communicate & coordinate with different stakeholders within the organization/ third party contract manufacturers to resolve any delay in submissionsLife 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 stakeholderApproval package compilation and provides support for lunching of the approved product
Job Title
15h Left: Regulatory Affairs Manager