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

About the role

This portfolio‑level regulatory strategy position will shape the pathway decisions, life‑cycle management and health‑authority relationships for a defined product portfolio across APAC, LATAM, MEA, CIS, Adriatics and Partner Business regions. Working closely with the Therapeutic Area Lead, you will translate global strategy into regionally credible submissions and feed regional intelligence back into the global plan.

Key responsibilities

• Develop and implement regional regulatory strategies aligned with global priorities, selecting the most efficient approval pathways.
• Provide strategic oversight of marketing applications, life‑cycle management, tender submissions and PSURs, anticipating regulatory risk.
• Ensure high‑quality submission documentation and timely health‑authority responses that meet regional requirements.
• Collaborate with Local Regulatory Responsible (LRR) and Regulatory Partner Representative (RPR) colleagues to gather input and maintain strong relationships.
• Stay up‑to‑date on international legislation, rare‑disease, orphan‑drug, toll‑manufacturing and reliance pathway considerations.

Required profile

• Substantial experience in regulatory affairs within pharma or biotech, with direct exposure to APAC, LATAM or comparable emerging‑market regulatory environments.
• Degree in Biological or Medical Science, Pharmacy or a related field; postgraduate qualification preferred.
• Proven ability to balance scientific rigor with practical regulatory realities across multiple jurisdictions.

Required skills

What we offer

• Hybrid working model – three days on‑site at our Maidenhead office.
• Opportunity to influence global regulatory strategy across diverse markets.
• Collaborative environment with cross‑functional and regional stakeholders.