Regional Regulatory Lead — Strategy & Submissions

CSL; Glattbrugg; On-site; CHF 150,000 - 190,000; Full time

Job summary

CSL is seeking a Regional Regulatory Lead to drive regional regulatory strategies across APAC, LATAM, CIS, Adriatics, MEA and Partner Business. Based in Zurich or Maidenhead, the role partners with the Global Regulatory Lead to align regulatory plans with commercial priorities.

You will manage submissions, lifecycle activities, Health Authority interactions, and risk planning while supervising cross-functional collaboration with LRRs and RPRs to ensure timely approvals and high-quality

Qualifications

• A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification.
• At least 5 years of regulatory experience within international markets.
• English mandatory; additional language skills are a plus (e.g., French, Spanish, Russian).
• Understanding of GMP and GCP principles and pharmaceutical development requirements.

Responsibilities

• Serve as regional regulatory strategist for designated regions in alignment with global strategy.
• Develop and implement regional regulatory strategies meeting regional requirements and approval pathways.
• Contribute to global regulatory strategy and plan complex scientific questions with cross-functional teams.
• Lead strategic oversight of regulatory activities to drive optimal Health Authority outcomes.
• Ensure high-quality regulatory submission documentation and timely responses to authorities.

Skills

Regulatory strategy development

International regulatory experience

GMP/GCP knowledge

Stakeholder collaboration

English proficiency

Education

Biological/Medical Science or Pharmacy degree

Job description

CSL is seeking a Regional Regulatory Lead to drive regional regulatory strategies across APAC, LATAM, CIS, Adriatics, MEA and Partner Business. Based in Zurich or Maidenhead, the role partners with the Global Regulatory Lead to align regulatory plans with commercial priorities.

You will manage submissions, lifecycle activities, Health Authority interactions, and risk planning while supervising cross-functional collaboration with LRRs and RPRs to ensure timely approvals and high-quality