Manager II - Regulatory Operations

-        Finalization of regulatory strategy for every product registration and license maintenance activity in alignment with his/ her manager.

-        Timely execution of import registrations, variations/ post-approval changes, clinical trial/ investigation applications, regulatory compliance submissions as per the plan which includes ensuring collection, compilation, fee payment, QC and review of submission dossiers and filing through SUGAM or applicable portals of Indian Health Authority.

-        Maintenance of product licenses i.e. renewal /re-registration of manufacturing sites and import licenses/ timely retention fee payment for applicable licenses.

-        Follow-up with authorities, managing query-responses if any, till approvals/ closure of applications.

-        End-to-end handling of any product testing activities at government/ private laboratories as needed.

-        Managing label development through Alcon platforms (e.g. CLEAR) and finalization of redress labels, as per India labelling requirements and applicable regulations.

-        Managing end-to-end Veeva Vault RIM activities including record management of regulatory submission documentations as per Alcon processes, update the databases / share-point sites as appropriate.

-        Ensure compliance with all applicable regulations, QMS and corporate requirements for smooth running of business including filing NPPA compliance forms (Form V/ Vorm VI), wholesale license tracking across our warehouses, BIS requirements, Equipment type approval if any, etc.

-        Collaborate with local stakeholders like commercial and other support functions (Supply chain teams/ QA, etc.) and region/ global regulatory teams.

-        Safety reporting as per relevant Alcon SOPs.

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