Manager Submission Management

Job description

Your Role: In this pivotal role, you will lead and shape the Submission Management sub-team within Global Regulatory Affairs, ensuring that every regulatory submission meets the highest standards of quality, compliance, and timeliness. You will be accountable for the day-to-day performance of your team — setting priorities, coaching team members, and driving continuous improvement across submission processes. As the primary expert for electronic Common Technical Document (eCTD) and submission management, you will guide your team through complex regulatory challenges, harmonize activities across functional areas, and serve as a key point of contact for submission-related expertise. You will collaborate closely with cross-functional stakeholders to establish and monitor key performance indicators, support onboarding and capability development, and ensure the long-term sustainability of your team’s knowledge and capacity. Operating in a dynamic matrix environment, you will play a central role in streamlining regulatory operations and aligning submission activities with the broader strategic objectives of the organization. Who You Are: You bring 9 to 11 years of professional experience in regulatory publishing and submission management within the pharmaceutical industry, with at least 2 years in a team leadership or supervisory capacity. You hold a degree in Pharmacy, Life Sciences, or a related scientific discipline, or equivalent professional experience. You have deep expertise in electronic Common Technical Document (eCTD) standards and submission processes, and are recognized as a subject-matter authority in this area. You are proficient with regulatory information management platforms and electronic document management systems used in submission workflows. You have a proven track record of monitoring and improving compliance with submission standards, Health Authority requirements, and standard operating procedures. You communicate with clarity and confidence, and are skilled at building effective relationships with stakeholders across functions and geographies in a matrix organization. You demonstrate strong people leadership capabilities, including performance management, coaching, talent development, and fostering an inclusive and engaging team culture. You bring familiarity with electronic submission management tools and an interest in continuously improving submission quality and process efficiency.