<ul><li>Work as a team with country RA and stakeholders, strategist, commercial teams, to ensure timely and efficient regulatory processes for submission.</li><li>Manage post approval submissions for&nbsp;assigned market(s)</li><li>Manage post approval strategy (including timelines) and execution in alignment and partnering with key stakeholders (i.e. Global, Markets, Clusters, labelling team, Submissions Management, CMC) to ensure a submission ready dossier for the assigned market(s).</li><li>Liaise with CMC Product Strategists. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in regulations for assigned markets.</li><li>Ensure a submission planning and forecasting tool is utilized to update timelines when necessary, communicate changes to relevant partners.</li><li>Capable of authoring some local submission components in relevant databases.</li><li>Ensure submission packages are reviewed against local CMC requirements for consistency and completeness.</li><li>Liaise with the manufacturing sites for obtaining supporting documents as needed.</li><li>Ensure thorough understanding and application of the Hub procedures.</li><li>Participate in local and regional regulatory initiatives promoting a culture aligned with company which supports compliance, innovation and talent development and retention.</li><li>Assist in ensuring internal regulatory processes and procedures are well documented.</li><li>Understand local regulations and trends for assigned markets, as communicated by the Local Country Office.</li><li>Participate in cross-region projects for internal processes improvement and ensure implementation consistency within the team.</li><li>Additional responsibilities as assigned by supervisor</li></ul>