Maintain effective regional relationship with stakeholders to ensure communication /clarity of regulatory strategy and timelines.
Apply regulatory expertise for assigned Products/countries to enable preparation of high quality documentation and assure compliance with departmental procedures.
Assist and liaise with GCMC, global/product strategists, PGS, Submissions Management, In-Country Regulatory , ILG, ALIM, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and BoH requirements are met, ensuring a submission ready dossier. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations. Ensure a submission planning and forecasting tool is utilized to update timelines.
Assist and support all product lifecycle regulatory work, and liaise with GCMC, Submissions Management, Cluster/Market, and any other key stakeholders.
dispatch dossiers to In-Country Regulatory .
Regularly follow up with In-Country Regulatory Team on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.
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