Regional Regulatory Lead in Maidenhead

This is 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.

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

• 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 disease, orphan drug, toll manufacturing, and reliance pathway considerations.

Experience Required

• Substantial experience in regulatory affairs within pharma or biotech, with direct exposure to APAC, LATAM, or comparable emerging-market regulatory environments.
• A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification.
• Demonstrated ability to develop and execute regional regulatory strategy in alignment with global product strategy.
• Strong working knowledge of marketing application, life cycle management, and PSUR/reporting requirements across multiple jurisdictions.
• Experience engaging directly with health authorities, with a track record of clear, credible communication that supports positive outcomes.
• Comfort operating as a subject matter expert — assessing regulatory impact, identifying risk, and advising cross-functional teams accordingly.
• A collaborative style suited to matrixed, multi-stakeholder environments, with the judgment to prioritize across a live portfolio.
• English is mandatory, while additional language skills would be an asset (e.g. Arabic, French, Spanish, Russian).