Regional Regulatory Lead – APAC, LATAM & Partner Business

Global Regulatory Affairs | Therapeutic Area: Immunoglobulins

As Regional Regulatory Lead (RRL), you will be responsible for defining and driving the regional regulatory strategy and its execution for a diverse portfolio of Immunoglobulin products across APAC, LATAM, and Partner Business markets.

In this highly visible and strategically important role, you will shape and implement regional regulatory strategies, ensure compliance with local and regional requirements, and actively contribute to global regulatory planning in close collaboration with the Therapeutic Area Lead.

Working closely with Local Regulatory Representatives and cross-functional stakeholders, you will support timely product approvals, maintain lifecycle compliance, and lead effective interactions with Health Authorities.

Key Responsibilities

As Regional Regulatory Lead, you will:

• Act as the regional regulatory strategist for the assigned product portfolio, ensuring alignment with global priorities.

• Develop and execute regional regulatory strategies, integrating local requirements and identifying efficient approval pathways.

• Participate in Global Strategy Teams (GRAST) and contribute to global regulatory planning, including complex scientific assessments as required.

• Oversee all regional regulatory activities, including new drug applications, renewals, variations, PSURs, and HA interactions.

• Ensure high‑quality preparation of regulatory documentation and responses to Health Authority questions.

• Build strong, collaborative relationships with Local Regulatory Representatives, Manufacturing, Supply Chain, Medical Affairs, and other internal partners.

• Maintain constructive, influential interactions with Health Authorities to drive positive outcomes in collaboration with Local Regulatory Representatives,

• Stay abreast of international and regional regulations relevant to CSL products, including rare diseases, orphan drugs, toll manufacturing, and reliance pathways.

• Act as a regional subject matter expert, proactively identifying regulatory risks and providing clear, expert guidance to stakeholders.

• Contribute to process improvement initiatives and support the development of training materials and best practices.

About You – Qualifications & Experience

You will be successful in this role if you bring:

• A degree in Biological or Medical Sciences, Pharmacy, or a related field; postgraduate qualifications (e.g., in Drug Regulatory Affairs) are an advantage.

• Minimum 5 years of regulatory experience in international markets, ideally within the pharmaceutical/biotech industry.

• Strong understanding of scientific principles, pharmaceutical development, and GMP requirements.

• Fluency in English (mandatory); additional languages such as Arabic, French, Spanish, or Russian are an asset.

• Demonstrated ability to manage complex regulatory activities, influence stakeholders, and navigate diverse regulatory environments.

Why Join Us?

This is a unique opportunity to play a strategic role in bringing critical therapies to patients across dynamic and fast‑growing regions. You will join a global team committed to innovation, collaboration, and continuous improvement.

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.

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