Regional Regulatory Strategy Lead — Submissions & Leadership

Confidential; Singapore; In loco; SGD 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

Confidential is seeking a Regional Regulatory Affairs Project Lead to drive regulatory strategy and execution across APAC markets. You will lead multi-market submissions, coordinate with cross-functional teams, and act as the primary regulatory interface with internal stakeholders and licensors.

The role requires 5-7 years in regulatory affairs, familiarity with ASEAN/ICH/PIC/S, and a proactive, detail-oriented mindset to ensure compliant, timely registrations and lifecycle management.

Competenze

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related field.
• 5-7 years in regulatory affairs (pharma/biotech/medical device).
• Familiarity with regional requirements (ASEAN, ICH, PIC/S).
• Experience with multi-market submissions and cross-functional teams.

Mansioni

• Develop regional regulatory strategies to support APAC markets.
• Lead end-to-end submission planning (CTD/eCTD).
• Coordinate with cross-functional teams to drive project execution.
• Interface with internal stakeholders and licensors.
• Monitor regulatory trends and provide timely intelligence.

Conoscenze

Regulatory affairs

Project leadership

Cross-functional collaboration

Documentation & compliance

Formazione

Bachelor's degree in Pharmacy/Life Sciences/Chemistry

Strumenti

CTD/eCTD knowledge

Descrizione del lavoro

Confidential is seeking a Regional Regulatory Affairs Project Lead to drive regulatory strategy and execution across APAC markets. You will lead multi-market submissions, coordinate with cross-functional teams, and act as the primary regulatory interface with internal stakeholders and licensors.

The role requires 5-7 years in regulatory affairs, familiarity with ASEAN/ICH/PIC/S, and a proactive, detail-oriented mindset to ensure compliant, timely registrations and lifecycle management.