Regulatory Affairs & Pharmacovigilance Lead – Indonesia

Siloam Hospitals Group; Tangerang; On-site; IDR 350,000,000 - 700,000,000; Full time

Benefits offered by this job

Career development

Global exposure

Competitive compensation

Job summary

Fresenius Medical Care is seeking a Regulatory Affairs Manager to lead regulatory submissions and lifecycle management for our product portfolio in Indonesia. You will ensure compliance with local and global requirements, maintain licenses, and collaborate with cross-functional teams to enable timely approvals.

The role requires 8–10 years in Regulatory Affairs, strong familiarity with pharmacovigilance, and the ability to influence senior stakeholders while driving regulatory strategy in a

Qualifications

• 8-10 years of progressive experience in Regulatory Affairs in pharma, medical devices, biotech, or healthcare.
• Strong knowledge of regulatory requirements, lifecycle management, and compliance.
• Experience leading regulatory submissions, interactions with authorities, and cross-functional collaboration.
• Proactive in risk assessment and ensuring patient safety through compliance.

Responsibilities

• Prepare and execute regulatory submissions and annual reports for authorities.
• Maintain regulatory files, licenses, and product registrations; ensure device and drug compliance.
• Lead regulatory strategy for variations and lifecycle activities across products.
• Support pharmacovigilance operations and post-market surveillance.
• Assist audits and provide regulatory input to minimize non-compliance findings.

Skills

Regulatory Affairs

Pharmacovigilance

Stakeholder management

Project management

Regulatory submissions

Job description

Fresenius Medical Care is seeking a Regulatory Affairs Manager to lead regulatory submissions and lifecycle management for our product portfolio in Indonesia. You will ensure compliance with local and global requirements, maintain licenses, and collaborate with cross-functional teams to enable timely approvals.

The role requires 8–10 years in Regulatory Affairs, strong familiarity with pharmacovigilance, and the ability to influence senior stakeholders while driving regulatory strategy in a