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 Maidenhead (hybrid, 3 days a week on-site) as you collaborate with the Therapeutic Area Lead to set the regional regulatory strategy for a defined product portfolio. This isn’t just about chasing approvals; it’s about shaping the pathway decisions, lifecycle management, and health authority relationships that ensure our global strategy truly resonates on the ground.

Why It Matters

A successful global regulatory strategy hinges on strong regional insights. Unlike the US or EU, regions like APAC, LATAM, MEA, CIS, and the Adriatics have their own dynamics—different evidentiary bars, timelines, and risk assessments. Missteps can lead to costly delays in approvals and access. In this role, you’ll own the judgment that transforms global strategy into regionally credible submissions, ensuring that regional intelligence informs global thinking proactively.

What You'll Be Responsible For

As the regional regulatory strategist for your product portfolio, you’ll blend scientific rigor with the practical realities of various regulatory systems. Your ability to build relationships—both internal and external—will be key to achieving timely approvals. Here’s what you’ll be doing:

• Develop and implement regional regulatory strategies that align 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, lifecycle 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

We’re looking for someone with a robust background in regulatory affairs within pharma or biotech, particularly in APAC, LATAM, or similar emerging-market regulatory environments. Here’s what you’ll need:

• Substantial experience in regulatory affairs, with direct exposure to relevant regulatory environments.
• A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification.
• Proven ability to develop and execute regional regulatory strategies that align with global product strategies.
• Strong working knowledge of marketing applications, lifecycle management, and PSUR/reporting requirements across multiple jurisdictions.
• Experience engaging directly with health authorities, demonstrating clear and credible communication that supports positive outcomes.
• Comfort operating as a subject matter expert—assessing regulatory impact, identifying risks, and advising cross-functional teams.
• 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 a valuable asset.