Regulatory Science Lead Intercontinental
Job Summary
Make your mark for patients
We are looking for aRegulatory 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 crossregional and crossfunctional 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
- You will build and implement IC regulatory strategies that fit global asset plans and business priorities.
- You will translate global strategies into IC specific plans considering local requirements and evolving HA expectations meeting local needs and balancing benefitrisk.
- You will coordinate submission content with global regional and affiliate colleagues so dossiers are accurate complete and ready for each country.
- You will lead submission planning preparation and delivery across the lifecycle: registrations variations renewals and postapproval commitments.
- You will deliver regulatory submissions in line with agreed strategies timelines and quality standards.
- 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
- You will bring a bachelors degree (masters or PhD preferred) in a scientific medical or related discipline.
- You will have 8 years in pharma including substantial regulatory affairs experience and working knowledge of IC procedures.
- You will have driven and delivered strategies and submissions across development registration line extensions and/or license maintenance.
- 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.
- You will plan and prioritize well solving problems pragmatically while protecting quality timelines and compliance.
- 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!
About us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe inspired by patients and driven by science.
Why work with us
At UCB we dont just complete tasks we create value. We arent afraid to push forward collaborate and innovate to make our mark for patients. We have a caring supportive culture where everyone feels included respected and has equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats on our patients our employees or our planet. Working for us you will discover a place where you can grow and have the freedom to carve your own career path to achieve your full potential.
At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
About Company
UCB – Inspired by patients. Driven by science. At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We're here because we want to transform patients’ lives by pushing the boundaries of what is possible.To achieve our ambition, we w ... View more