Leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissionsTakes a proactive role in the critical review of molecule specific GRA-CMC development strategies and submission content. Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRA-CMC regulatory scientists.Provide high quality, timely and clear regulatory advice to allow CMC teams to make well-informed decisionsEvaluate regulatory impact on proposed CMC development plansCommunicates effectively verbally and in writing to influence within GRA-CMC and with CMC development team.Partners with Client GRA CMC (regulatory scientists) develop complex regulatory strategies.Partners with Client RDE (regulatory associates/publishing group) to ensure completion of submission activities.
