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

The Role

Are you ready to take on a portfolio-level regulatory strategy role that spans diverse regions with unique regulatory requirements and market dynamics? Join us in shaping the future of healthcare across APAC, LATAM, MEA, CIS, Adriatics, and Partner Business Regions.

In collaboration with the Therapeutic Area Lead, you will set the regional regulatory strategy for a defined product portfolio. This isn’t just about chasing individual approvals; it’s about shaping pathway decisions, managing life cycles, and building health authority relationships that ensure our global strategy is effectively implemented on the ground.

Location: Maidenhead/Hybrid, with 3 days a week on-site.

Why It Matters

A successful global regulatory strategy relies on strong regional insights. Each region has its own dynamics, differing from the US or EU—different evidentiary bars, timelines, and risk calculations. Missteps can lead to costly delays in approvals and access. In this role, you will own the judgment necessary to turn global strategies into regionally credible submissions, ensuring that regional intelligence informs global thinking proactively.

What You'll Be Responsible For

• Act as the regional regulatory strategist for your product portfolio, balancing scientific rigor with the practical realities of various regulatory systems.
• Develop and implement regional regulatory strategies aligned with 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, planning and responding to complex scientific questions that require product expertise and cross-functional input.
• Provide strategic oversight of submissions—marketing applications, life cycle management, tender applications, and PSURs—anticipating regulatory risks before they cause delays.
• Ensure high-quality submission documentation and health authority responses are delivered on schedule and meet regional requirements.
• Build and sustain strong working relationships with LRRs, RPRs, internal stakeholders, and regional health authorities.
• 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, showcasing a track record of clear, credible communication that supports positive outcomes.
• Comfort operating as a subject matter expert—assessing regulatory impact, identifying risks, and advising cross-functional teams accordingly.
• A collaborative style suited to matrixed, multi-stakeholder environments, with the judgment to prioritize across a live portfolio.
• Fluency in English is mandatory; additional language skills (e.g., Arabic, French, Spanish, Russian) would be an asset.