Regional Regulatory Lead

The Regional Regulatory Lead (RRL) is responsible for both strategic and operational regulatory activities within the assigned Therapeutic Area (TA) for designated products across designated regions or sub-regions: Asia Pacific (APAC), Latin America (LATAM), Commonwealth of Independent States (CIS), Adriatics, Middle East & Africa (MEA) and Partner Business. Working with the Therapeutic Area Lead and the Global Regulatory Lead, the RRL contributes to global regulatory strategy and manages regional regulatory strategies that align with commercial and business priorities.

This position ensures adherence to regional regulatory requirements and oversees submissions related to marketing applications, life cycle management, tender applications, interactions with Health Authorities, PSURs, and associated reporting responsibilities. The RRL partners with Local Regulatory Representative (LRR), Regulatory Partner Representative (RPR), and other internal stakeholders to facilitate timely Health Authority approvals.

Key Responsibilities

Serve as the regional regulatory strategist for the assigned product portfolio and countries in alignment with the global strategy and priorities across designated regions or sub-regions: Asia Pacific (APAC), Latin America (LATAM), Commonwealth of Independent States (CIS), Adriatics, Middle East & Africa (MEA) and Partner Business.

Develop and implement regulatory strategies that meet regional requirements for any regulatory activities, while identifying the most efficient approval pathways by leveraging LRR or RPR local inputs.

Contribute to RST activities and support the development of Global Regulatory Strategy, including planning and preparation of projects or response for complex scientific questions that require product expertise and cross-functional collaboration.

Lead the strategic oversight of regulatory activities across the assigned product portfolio and countries to drive optimal Health Authority outcomes and proactively anticipate and manage emerging regulatory risks.

Provide strategic oversight to ensure high-quality regulatory submission documentation for all regulatory activities, including responses to Health Authority questions, aligned with schedules and regional requirements, while fostering a culture of continuous improvement.

Build and maintain strong collaboration with Local Regulatory Representatives (LRR), Regulatory Partner Representatives (RPR), and other internal stakeholders.

Build and maintain strong relationships with regional Health Authorities by delivering high quality, compliant regulatory documentation and engaging with clarity and influence to support positive outcomes for CSL.

Stay current with international legislation and guidelines relevant to any CSL products and other key related CSL activities and initiatives (e.g. rare diseases, orphan drugs, toll manufacturing, reliance pathways).

Act as a subject matter expert by assessing the impact of local or regional regulation and identifying potential regulatory risks.

Contribute to continuous process improvements to enhance regulatory execution, compliance, and operational excellence.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

At CSL, we are committed to continuous improvement, scientific excellence, and making a meaningful difference in patients’ lives. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

• A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous

• At least 5 years of regulatory experience within the international markets, supported by additional pharmaceutical /industry experience.

• English mandatory, and additional language is an asset (e.g. Arabic, French, Spanish, Russian)

• Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product and understanding of the principles of GMP, GCP.