Regulatory Affairs Manager, Medical Devices & PV

Pt Guna Prakasa Utama; Jawa Barat; On-site; IDR 167,400,000 - 312,480,000; Full time

Job summary

Fresenius Medical Care in Indonesia seeks a Regulatory Affairs Manager to ensure regulatory compliance and oversee submissions to local health authorities. The role requires maintaining licenses, registrations, and adherence to global safety standards across the lifecycle of products.

The candidate will coordinate pharmacovigilance activities, monitor safety signals, and collaborate with cross-functional teams to support product approvals and lifecycle management in a regulated market.

Qualifications

• Regulatory submissions to Indonesian health authorities and maintenance of licenses.
• Support pharmacovigilance activities and device/drug safety compliance.
• Collaborate with internal teams to ensure lifecycle management.

Responsibilities

• Prepare regulatory submissions and annual reports for authorities.
• Maintain regulatory files and licenses; renewals and registrations.
• Oversee pharmacovigilance operations for marketed products.
• Lead communications with health authorities to resolve regulatory issues.

Job description

Fresenius Medical Care in Indonesia seeks a Regulatory Affairs Manager to ensure regulatory compliance and oversee submissions to local health authorities. The role requires maintaining licenses, registrations, and adherence to global safety standards across the lifecycle of products.

The candidate will coordinate pharmacovigilance activities, monitor safety signals, and collaborate with cross-functional teams to support product approvals and lifecycle management in a regulated market.