Regional Regulatory Lead

CSL; Maidenhead; On-site; GBP 90,000 - 120,000; Full time

Job summary

CSL is seeking a Regional Regulatory Lead to drive strategic and operational regulatory activities across multiple regions, including APAC, LATAM, CIS, Adriatics, MEA and partner business. The role partners with the Therapeutic Area Lead and Global Regulatory Lead to shape regional strategy and ensure compliant submissions.

The ideal candidate has 5+ years of international regulatory experience in the pharma sector, with GMP/GCP knowledge and English as a must.

Qualifications

• Degree in Biological or Medical Science or Pharmacy; post-graduate qualification advantageous.
• At least 5 years regulatory experience in international markets, with pharma/industry background.
• English fluency mandatory; additional languages are a plus.
• Understanding of GMP/GCP principles and regulatory standards.

Responsibilities

• Serve as regional regulatory strategist for designated product portfolio and regions, aligning with global strategy.
• Develop and implement regional regulatory strategies to meet requirements and optimize approval pathways.
• Contribute to global regulatory strategy by planning for complex scientific questions and cross-functional collaboration.
• Provide strategic oversight to regulatory activities and ensure timely, compliant submissions.
• Build strong relationships with Local Regulatory Representatives, Regulatory Partner Representatives, and health authorities.

Skills

Regulatory strategy

Stakeholder management

Global/regional regulation

GMP/GCP knowledge

Education

Biological/Medical Science or Pharmacy degree

Job description

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. The RPL can be based at either of the following sites: Zurich (Switzerland), or Maidenhead (UK).

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.

Your Profile

• 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.

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.