Regional Regulatory Lead - APAC, LATAM and Partner Business Regions

We are looking for a strategic and collaborative Regional Regulatory Lead (RRL) to join our Global Regulatory Affairs team.

In this role, you will lead both strategic and operational regulatory activities within an assigned Therapeutic Area (TA) across APAC, LATAM, and Partner Business Regions. You will work closely with global and regional stakeholders to ensure timely regulatory approvals and successful lifecycle management for designated products.

Partnering with the Therapeutic Area Lead and the Global Regulatory Lead, you will contribute to global regulatory strategies while adapting and executing regional strategies aligned with business and commercial priorities.

This is an exciting opportunity to play a key role in bringing critical therapies to patients across dynamic and fast-growing international markets.

Key Responsibilities

• Act as the regional regulatory lead for assigned products and countries, ensuring alignment with global regulatory strategy and priorities.

• Develop and implement regional regulatory strategies that support product registrations, lifecycle management, and business objectives.

• Identify efficient regulatory approval pathways in collaboration with Local Regulatory Representatives (LRRs) and Regulatory Partner Representatives (RPRs).

• Contribute to Global Regulatory Affairs Strategy Team (GRAST) activities and support the development of global regulatory strategies.

• Lead and oversee regulatory activities across the assigned portfolio, proactively identifying and managing regulatory risks.

• Ensure high-quality regulatory submissions and responses to Health Authority questions in line with regional requirements and timelines.

• Collaborate closely with internal stakeholders, LRRs, and RPRs to support timely approvals and regulatory compliance.

• Build and maintain strong relationships with regional Health Authorities through effective communication and high-quality documentation.

• Stay informed on international regulatory legislation, guidelines, and industry developments relevant to CSL products and activities.

• Assess the impact of evolving local and regional regulations and provide regulatory risk assessments.

• Support continuous improvement initiatives to enhance regulatory processes, compliance, and operational excellence.

Qualifications & Experience

Education

• Degree in Biological Sciences, Medical Sciences, Pharmacy, or a related field.

• Postgraduate qualifications or specialization in Drug Regulatory Affairs are considered an advantage.

Experience

• Minimum 5 years of regulatory affairs experience within international markets.

• Additional pharmaceutical or biotech industry experience is highly desirable.

Skills & Competencies

• Fluent English is required.

• Additional languages are considered an asset (e.g., Arabic, French, Spanish, Russian).

• Strong understanding of pharmaceutical product development and regulatory requirements.

• Knowledge of GMP and GCP principles.

• Excellent communication, stakeholder management, and organizational skills.

• Ability to work effectively in a global and cross-functional environment.

Why Join Us?

This is a unique opportunity to contribute to the delivery of life-changing therapies to patients worldwide while working within a collaborative and innovative global environment.

At CSL, we are committed to continuous improvement, scientific excellence, and making a meaningful difference in patients’ lives.

Was wir bieten

Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, was wir bei CSL bieten .

Über CSL Behring

CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring .

CSL soll so vielfältig sein wie die Welt, in der wir leben

Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über Vielfalt, Fairness & Inklusion bei CSL.

Machen Sie mit Ihrer Arbeit bei CSL einen Unterschied!