Regional Regulatory Lead - Global Strategy & Compliance

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

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.