Global Submission LeadGlobal Role | Regulatory Affairs | Pharma / Biotech
Contract: Contract Role until December 2026 (with possibility of extension!)Location: On-site in Anderlecht
I'm currently partnering with a global organisation looking to bring on a Global Submission Lead to drive the planning, coordination, and execution of regulatory submissions across multiple regions.
This is a highly visible role where you'll work cross-functionally, leading submission teams and ensuring delivery against key timelines while maintaining high-quality regulatory standards.
What you'll be doing:Lead the development and execution of global submission strategiesCoordinate cross-functional teams to ensure alignment with submission plansProactively identify risks, solve challenges, and drive projects forwardManage stakeholders across multiple functions, building strong collaborative relationshipsDeliver clear and effective communication to both internal and external stakeholdersSupport continuous improvement initiatives and optimise ways of workingContribute to training and onboarding within the team
What we're looking for:5+ years' experience in pharma, biotech, CRO, or drug development environmentStrong understanding of regulatory processes and submissions (e.g. CTD)Proven project management and stakeholder management experienceExcellent communication, leadership, and influencing skillsAbility to manage complexity, prioritise effectively, and work independentlyDegree in a scientific, engineering, or healthcare-related field (preferred)Experience with project management methodologies (e.g. PMI, PRINCE2) is a plus.