- Responsible for preparation, review and submission of new market authorizations forexpansion in Latin America market.- Accountable for the preparation, review and submission of renewal documentation forexisting drug product registrations to maintain business- Managed maintenance of Dossiers by ensuring updates are accurately translated- Effectively communicate with distributors regarding variation updates related to registereddrug products, ensuring accuracy- Responsible for preparation, review and submission of labeling for new marketauthorizations, name changes and or other miscellaneous label changes related to LatinAmerica.- Lead monthly discussions with internal customers at all levels in Commercial and SupplyChain as appointed RA Specialist.- Create and / or approve change controls for label changes in Trackwise database.- Track all label revisions ensuring accuracy- Weekly interaction with Distributors to ensure submissions are proceeding as expected

- Provide regulatory expertise and authorization of internal documents for label control andusage- Prepare and review labeling for NDAs, ANDAs, amendments, supplements and othersubmissions to FDA.- Provide new label and package inserts for new NDAs.- Prepare label reviews for approximately 15 annual reports and 15 PADERs per year.- Generate and approve change control documents for label changes in TrackwiseTrack label revisions- Responsible for the review of SPLs prior to being included in FDA Submissions.- Assisted with the conversion of product package inserts to PLR format.- Accountable for updating labels to reflect company name changes. Approximately 100product labels per name change.