Make your mark for patients
We are looking for a Regulatory Science Lead – Intercontinental (IC) who is strategic, collaborative, and execution-driven to join our Global Regulatory Affairs team, based in our HQ in Brussels, Belgium.
About the role
You will set the regulatory approach for assigned products across IC markets and will turn global plans into clear regional and country strategies and submission plans. You will drive regulatory excellence across new registrations and lifecycle management, with accountability for enabling timely approvals and accelerating patient access.
Who you will work with
Operating in a highly cross‑regional and cross‑functional environment, you will serve as the primary regional contact point for the Global Regulatory Lead (GRL), global teams, and affiliates, ensuring aligned regulatory positioning, robust risk management, and effective execution. You will help teams stay coordinated across markets with diverse regulatory pathways, reliance models, and levels of regulatory maturity.
What you will do
1. You will build and implement IC regulatory strategies that fit global asset plans and business priorities.
2. You will translate global strategies into IC specific plans, considering local requirements and evolving HA expectations, meeting local needs and balancing benefit–risk.
3. You will coordinate submission content with global, regional, and affiliate colleagues so dossiers are accurate, complete, and ready for each country.
4. You will lead submission planning, preparation and delivery across the lifecycle: registrations, variations, renewals, and post‑approval commitments.
5. You will deliver regulatory submissions in line with agreed strategies, timelines and quality standards.
6. You will plan and support health authority (HA) interactions, including development of briefing documents, HA meeting packages, scientific responses and regulatory justifications.
Interested? For this role, we are looking for the following education, experience, and skills
7. You will bring a bachelor’s degree (master’s or PhD preferred) in a scientific, medical, or related discipline.
8. You will have 8+ years in pharma, including substantial regulatory affairs experience and working knowledge of IC procedures.
9. You will have driven and delivered strategies and submissions across development, registration, line extensions, and/or license maintenance.
10. You will communicate clearly and influence decisions across diverse stakeholders in a matrix environment, identifying opportunities and taking actions to build effective relationships within team and across function.
11. You will plan and prioritize well, solving problems pragmatically while protecting quality, timelines, and compliance.
12. You will show integrity, cultural awareness, adaptability, and a growth mindset, using new ways of working when helpful.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!