Submission Management: Develop and coordinate on the preparation, review, and submission of submission packages and regulatory documents for countries such as in Europe (European Union [Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic (Czechia), Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden], other European countries, UK, Norway, Switzerland, Iceland), Latin America, Asia Pacific (including Australia, New Zealand, China, South Korea), and rest of the world (ROW). In this role, they will excel in developing and executing global CTA submission strategies, ensuring compliance, managing submissions, fostering cross-functional collaboration, liaising with regulatory agencies, supervising quality assurance, and addressing regulatory risks associated with programs.