Regulatory Affairs Manager — Compliance & PV Leader

Pengiklan Anonim; Jawa Barat; On-site; IDR 350,000,000 - 600,000,000; Full time

Job summary

Fresenius Medical Care is seeking a Regulatory Affairs Manager in Indonesia to lead regulatory submissions, ensure compliance across healthcare products, and coordinate with authorities. The role emphasizes lifecycle management, labeling, and collaboration with internal teams to support patient safety and product approval processes.

The position requires experience in regulatory affairs within pharma or medical devices, strong strategic and communication skills, and a proactive, compliant

Qualifications

• Experience in regulatory affairs within pharmaceutical/medical device/healthcare industries.
• Strong understanding of regulatory strategies and lifecycle management.
• Excellent stakeholder management and project coordination skills.

Responsibilities

• Prepare regulatory submissions and maintain regulatory files to compliant standards.
• Monitor regulatory requirements and ensure product labeling and promotional materials meet regulations.
• Support pharmacovigilance activities and participate in audits and inspections.

Job description

Fresenius Medical Care is seeking a Regulatory Affairs Manager in Indonesia to lead regulatory submissions, ensure compliance across healthcare products, and coordinate with authorities. The role emphasizes lifecycle management, labeling, and collaboration with internal teams to support patient safety and product approval processes.

The position requires experience in regulatory affairs within pharma or medical devices, strong strategic and communication skills, and a proactive, compliant