Regional Regulatory Strategy Lead: APAC, LATAM, MEA & CIS

CSL

Thatcham

Hybride

GBP 90 000 - 120 000

Plein temps

Il y a 7 jours
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Résumé du poste

CSL Seqirus is seeking a portfolio-level regulatory strategist to set regional strategy across APAC, LATAM, MEA, CIS, Adriatics and Partner Regions. Based in Maidenhead with a hybrid setup, you will work 3 days on-site to align with global strategy and regional requirements.

You’ll influence life-cycle management and health authority interactions beyond single approvals. You will collaborate with LRR, RPR and cross-functional teams to ensure timely, compliant submissions and practical pathway

Qualifications

  • Substantial experience in regulatory affairs in pharma/biotech.
  • Direct exposure to APAC, LATAM, or comparable emerging-market regulatory environments.
  • Strong knowledge of marketing applications, lifecycle management, and PSUR/reporting requirements across jurisdictions.
  • Experience engaging with health authorities and cross-functional teams with clear, credible communication.

Responsabilités

  • Develop and implement regional regulatory strategies aligned to global priorities.
  • Contribute to Global Regulatory Strategy activities with cross-functional input.
  • Provide strategic oversight of submissions and lifecycle activities.
  • Ensure high-quality submission documentation and health authority responses on schedule.
  • Build strong relationships with local regulatory representatives and regional authorities.
  • Stay current on international legislation relevant to CSL Seqirus.

Connaissances

Regional regulatory strategy
Regulatory submissions
PSUR reporting
Health authority engagement
English language

Formation

Biological science degree
Pharmacy degree
Post-graduate qualification

Description du poste

CSL Seqirus is seeking a portfolio-level regulatory strategist to set regional strategy across APAC, LATAM, MEA, CIS, Adriatics and Partner Regions. Based in Maidenhead with a hybrid setup, you will work 3 days on-site to align with global strategy and regional requirements.

You’ll influence life-cycle management and health authority interactions beyond single approvals. You will collaborate with LRR, RPR and cross-functional teams to ensure timely, compliant submissions and practical pathway

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