Regional Regulatory Lead - APAC, LATAM, MEA, CIS, Adriatics and Partner Business in Thatcham

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.

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 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 skill would be an asset (e.g. Arabic, French, Spanish, Russian).