Regional Regulatory Strategy Lead for Global Portfolio

CSL; Reading; Hybride; GBP 90 000 - 120 000; Plein temps

Résumé du poste

CSL is seeking a portfolio-level regulatory strategist to shape regional strategy across APAC, LATAM, MEA and other regions. You will partner with the Therapeutic Area Lead to translate global strategy into regionally credible submissions, managing life cycle decisions and health authority relationships.

Based in Maidenhead with a hybrid model (3 days on-site), you will build regional insights, identify efficient approval pathways, and provide strategic oversight of submissions and PSURs across

Qualifications

• Substantial experience in regulatory affairs within pharma or biotech, with exposure to APAC or LATAM.
• Degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification.
• Ability to develop and execute regional regulatory strategy aligned with global product strategy.
• Knowledge of marketing applications, life cycle management, and PSUR/reporting across jurisdictions.
• Experience engaging with health authorities and clear, credible communication.
• Collaborative style for matrixed environments; prioritising across a live portfolio.
• English mandatory; additional languages are a plus.

Responsabilités

• Develop and implement regional regulatory strategies aligned to global priorities.
• Identify efficient approval pathways with input from Local Regulatory Responsible (LRR) and Regulatory Partner Representative (RPR).
• Contribute to Global Regulatory Strategy activities, including planning and complex scientific questions.
• Provide strategic oversight of submissions — marketing applications, life cycle management, tender applications, and PSURs.
• Ensure high-quality submission documentation and health authority responses, delivered on schedule.
• Build and sustain relationships with LRRs, RPRs, internal stakeholders, and regional health authorities.
• Stay current on international legislation and guidance relevant to CSL's products and initiatives.

Connaissances

Regulatory affairs

Regional strategy

Health authorities

Cross-functional collaboration

English language

Risk assessment

Formation

Biological/Medical Science or Pharmacy degree

Post-graduate qualification

Description du poste

CSL is seeking a portfolio-level regulatory strategist to shape regional strategy across APAC, LATAM, MEA and other regions. You will partner with the Therapeutic Area Lead to translate global strategy into regionally credible submissions, managing life cycle decisions and health authority relationships.

Based in Maidenhead with a hybrid model (3 days on-site), you will build regional insights, identify efficient approval pathways, and provide strategic oversight of submissions and PSURs across