Hub Submissions Manager

• Degree in Life Sciences, Pharmacy, Business, IT, or related discipline
• Demonstrated experience in regulatory submissions or regulatory operations within the pharmaceutical or life sciences industry
• Strong project management and coordination skills
• Excellent attention to detail and ability to manage multiple complex deliverables
• Proficiency with electronic submission systems, dossier structures, and regulatory tools
• For senior levels: proven leadership experience, deep understanding of submission processes, and ability to mentor others

In this role, you will play a pivotal part in managing the global regulatory submission lifecycle:

• Oversee end-to-end delivery of regulatory submissions for assigned products
• Coordinate cross-functional teams to meet submission timelines and quality expectations
• Manage operational aspects such as planning, document flow, translations, and submission build
• Act as the connection between global, regional, and local teams to align on regulatory requirements
• Drive process optimisation and continuous improvement initiatives
• For senior levels: lead cross-functional strategic projects, represent the organisation in global discussions, and contribute to policy and process development

• Proficiency in submission management systems and electronic publishing tools
• Deep understanding of global regulatory frameworks
• Strong communication and stakeholder engagement across international teams
• Analytical mindset with the ability to work under pressure and deliver to tight deadlines
• Capability to influence, mentor, and drive best practices within matrix environments

• Experience with document management systems or regulatory information management tools
• Additional language skills for global coordination
• Background in process improvement or digital transformation in regulatory operations