Regulatory Affairs & PV Manager

Freseniusmedicalcare; Jakarta Selatan; On-site; IDR 420,000,000 - 720,000,000; Full time

Job summary

Fresenius Medical Care Indonesia seeks a regulatory compliance and pharmacovigilance professional to manage submissions to health authorities, maintain licenses, and ensure adherence to safety standards across products and markets.

You will collaborate with internal teams and regulators to support approvals, lifecycle management, labeling reviews, and audits, with potential duties as Deputy QPPV and Company Responsible Pharmacist as required.

Responsibilities

• Prepare (write, analyse, and edit) regulatory submissions to authorities (Ministry of Health, NADFC/BPOM, Ministry of Law and Human Rights) and ensure format compliance.
• Communicate submission requirements with internal teams and third parties to support regulatory filings.
• Maintain regulatory files, licenses, registrations, renewals, and device listings across regions.
• Prepare responses to inquiries/deficiency questions within assigned timelines.
• Develop regulatory strategies for variation applications for pharma and medical device products.
• Stay updated on regulatory procedures and changes; communicate updates to stakeholders.
• Lead negotiations with health authorities during development, registration, and lifecycle activities.
• Assess device-related incidents/complaints for medical device reporting and recalls when needed.
• Support external regulatory audits with regulatory input; review product labels and promotional material for compliance.
• Assist in listing communications and respond to authority inquiries; act as Company Responsible Pharmacist if required.

Job description

Fresenius Medical Care Indonesia seeks a regulatory compliance and pharmacovigilance professional to manage submissions to health authorities, maintain licenses, and ensure adherence to safety standards across products and markets.

You will collaborate with internal teams and regulators to support approvals, lifecycle management, labeling reviews, and audits, with potential duties as Deputy QPPV and Company Responsible Pharmacist as required.