Geo Expansion Regulatory Lead

Opella; Jakarta Pusat; Sur place; IDR 900 000 000 - 1 300 000 000; Plein temps

Résumé du poste

Opella in Jakarta, Indonesia seeks an ASEA Geo Expansion Regulatory Manager to drive regulatory strategy across ASEA markets, enabling geo expansions and product approvals in line with local regulations. You will lead cross-functional teams, manage dossiers, and ensure compliant execution for new geographic entries.

The role emphasizes governance, data integrity, and stakeholder collaboration, with focus on lifecycle management, variations, and continuous process optimization across regional

Qualifications

• Education: Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences (Nursing, Dietetics, Pharmacology), MPh or master's degree.
• 5+ years in innovation or regulatory affairs in consumer healthcare, OTC, personal care or FMCG.
• Ability to lead cross-local RA teams across ASEA region and work with cross-functional teams across geographies.

Responsabilités

• Regulatory Strategy Execution: lead and implement ASEA science strategy for geographic expansion to support business growth.
• Dossier Management: plan and manage regulatory submissions and responses with cross-functional teams.
• Lifecycle Management: oversee renewals, variations, and discontinuations to ensure compliant execution.
• Compliance & Data Integrity: maintain regulatory databases and ensure updates with affiliate feedback and changes.
• Risk & Stakeholder Management: coordinate communication across internal and external stakeholders and mitigate risks.

Connaissances

Regulatory leadership

Cross-functional leadership

Project management

English proficiency

Stakeholder management

Strategic thinking

Formation

Medical/Health sciences degree

Outils

Regulatory databases

Description du poste

Opella in Jakarta, Indonesia seeks an ASEA Geo Expansion Regulatory Manager to drive regulatory strategy across ASEA markets, enabling geo expansions and product approvals in line with local regulations. You will lead cross-functional teams, manage dossiers, and ensure compliant execution for new geographic entries.

The role emphasizes governance, data integrity, and stakeholder collaboration, with focus on lifecycle management, variations, and continuous process optimization across regional