About the job
The Role
This a portfolio-level regulatory strategy role covering regions with diverse regulatory requirements and market dynamics: APAC, LATAM, MEA, CIS, Adriatics and Partner Business Regions. Working with the Therapeutic Area Lead, you'll set regional regulatory strategy for a defined product portfolio — not just chasing individual approvals, but shaping the pathway decisions, life cycle management, and health authority relationships that determine how well global strategy actually lands on the ground.
Location: Maidenhead/Hybrid, 3-days a week on-site
Why It Matters
A global regulatory strategy depends on strong regional insights across all markets. These regions do not follow the same dynamics as the US or EU — different evidentiary bars, different timelines, different risk calculus — and getting that wrong costs approval time and access. This role owns that judgment: turning global strategy into regionally credible submissions and pushing regional intelligence back up into global thinking before it becomes a problem rather than after.
What You'll Be Responsible For
You'll act as the regional regulatory strategist for your product portfolio, balancing scientific rigor with the practical realities of dozens of different regulatory systems, while building the relationships — internal and external — that make timely approval possible.
Develop and implement regional regulatory strategies aligned to global priorities, identifying the most efficient approval pathways with input from Local Regulatory Responsible (LRR) and Regulatory Partner Representative (RPR) colleagues
Contribute to Global Regulatory Strategy activities, including planning and responding to complex scientific questions requiring product expertise and cross-functional input
Provide strategic oversight of submissions — marketing applications, life cycle management, tender applications, and PSURs — anticipating regulatory risk before it becomes a delay
Ensure high-quality submission documentation and health authority responses, delivered on schedule and to regional requirements
Build and sustain strong working relationships with LRRs, RPRs, internal stakeholders, and regional health authorities themselves
Stay current on international legislation and guidance relevant to CSL's products and initiatives, including rare d...
Regional Regulatory Lead in Maidenhead employer: CSL Behring
CSL is an exceptional employer that fosters a dynamic and inclusive work culture, offering employees the chance to lead innovative projects in regulatory affairs while enjoying the flexibility of a hybrid work model. With a strong commitment to professional development, CSL provides ample opportunities for growth and advancement, making it an ideal place for those seeking meaningful and rewarding careers in the healthcare sector.
