Regulatory Affairs Leader — Indonesia Compliance & PV

Octarine Perfume; Bogor; On-site; IDR 70,000,000 - 100,000,000; Full time

Job summary

Fresenius Medical Care in Indonesia seeks a Regulatory Affairs Manager to lead regulatory compliance, registrations, and submissions to the Indonesian health authorities. You will maintain licenses, ensure labeling and promotional materials meet regulations, monitor safety signals, support audits, and collaborate with cross-functional teams to enable product approvals and lifecycle management.

The role also acts as Deputy Qualified Pharmacovigilance Responsible Person, coordinating with QA,

Qualifications

• Regulatory submissions to Indonesian health authorities and maintenance of licenses.
• Ensure labeling and promotional materials comply with medical device and drug regulations.
• Monitor pharmacovigilance activities and support audits.
• Collaborate with internal teams to support product approvals and lifecycle management.

Responsibilities

• Prepare regulatory submissions and annual reports; maintain regulatory files.
• Ensure registered products comply with applicable regulations and standards.
• Oversee Pharmacovigilance operations and regulatory input for safety reporting.
• Communicate regulatory updates to internal stakeholders and support authority inquiries.
• Act as Company Responsible Pharmacist if required.

Job description

Fresenius Medical Care in Indonesia seeks a Regulatory Affairs Manager to lead regulatory compliance, registrations, and submissions to the Indonesian health authorities. You will maintain licenses, ensure labeling and promotional materials meet regulations, monitor safety signals, support audits, and collaborate with cross-functional teams to enable product approvals and lifecycle management.

The role also acts as Deputy Qualified Pharmacovigilance Responsible Person, coordinating with QA,