Regional Regulatory Lead - Global Strategy & Compliance

CSL; Glattbrugg; Presencial; CHF 130 000 - 170 000; Tempo integral

Resumo da oferta

CSL is seeking a Regional Regulatory Lead to shape and execute regulatory strategies across APAC, LATAM, CIS, Adriatics, MEA and Partner Business. Base sites are Zurich or Maidenhead; you will coordinate with LRR, RPR and Global Regulatory Lead to align regulatory plans with commercial priorities.

The role requires a biology/medical/pharmacy degree, 5+ years of international regulatory experience, strong GMP/GCP knowledge, and fluency in English.

Qualificações

• Degree in Biological/Medical Science or Pharmacy; post-graduate qualification in Drug Regulatory Affairs advantageous

Responsabilidades

• Serve as regional regulatory strategist for the assigned product portfolio and regions in alignment with global strategy.
• Develop and implement regional regulatory strategies meeting regional requirements and identify efficient approval pathways.
• Contribute to Global Regulatory Strategy and planning for complex scientific questions requiring cross-functional collaboration.
• Provide strategic oversight to ensure high-quality regulatory submission documentation and timely approvals.
• Build and maintain strong collaboration with Local Regulatory Representatives (LRR) and Regulatory Partner Representatives (RPR).
• Stay current with international legislation and guidelines relevant to CSL products and initiatives.
• Act as an SME by assessing impact of local/regional regulation and identifying regulatory risks.

Conhecimentos

Regulatory strategy development

Stakeholder management

Regulatory submissions

GMP/GCP knowledge

Cross-cultural collaboration

Formação académica

Degree in Biological or Medical Science or Pharmacy

Post-graduate qualification in Drug Regulatory Affairs

Descrição da oferta de emprego

CSL is seeking a Regional Regulatory Lead to shape and execute regulatory strategies across APAC, LATAM, CIS, Adriatics, MEA and Partner Business. Base sites are Zurich or Maidenhead; you will coordinate with LRR, RPR and Global Regulatory Lead to align regulatory plans with commercial priorities.

The role requires a biology/medical/pharmacy degree, 5+ years of international regulatory experience, strong GMP/GCP knowledge, and fluency in English.