Global Submission Lead
Global 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 strategies
* Coordinate cross-functional teams to ensure alignment with submission plans
* Proactively identify risks, solve challenges, and drive projects forward
* Manage stakeholders across multiple functions, building strong collaborative relationships
* Deliver clear and effective communication to both internal and external stakeholders
* Support continuous improvement initiatives and optimise ways of working
* Contribute to training and onboarding within the team
What we’re looking for:
* 5+ years’ experience in pharma, biotech, CRO, or drug development environment
* Strong understanding of regulatory processes and submissions (e.g. CTD)
* Proven project management and stakeholder management experience
* Excellent communication, leadership, and influencing skills
* Ability to manage complexity, prioritise effectively, and work independently
* Degree in a scientific, engineering, or healthcare-related field (preferred)
* Experience with project management methodologies (e.g. PMI, PRINCE2) is a plus.