Regulatory Affairs Trainee

Havi; Bekasi; On-site; IDR 550,000,000 - 750,000,000; Full time

Job summary

Fresenius Medical Care is hiring for a Regulatory Affairs Manager in Bekasi, Indonesia. You will manage regulatory compliance, prepare submissions, maintain licenses, and oversee pharmacovigilance activities to support product approvals and lifecycle management.

The role requires close collaboration with internal teams and regulators to ensure adherence to local and global standards, and to drive timely regulatory responses and labeling reviews across products.

Qualifications

• Minimum 8-10 years of progressive experience in Regulatory Affairs within the pharmaceutical, medical device, biotechnology, or healthcare industry.
• In-depth knowledge of pharmaceutical and medical device regulations, registration requirements, and lifecycle management processes.
• Strong capability to influence senior stakeholders and provide regulatory guidance to leadership teams.
• Strong understanding of local pharmacovigilance regulations, regulatory intelligence, emerging regulatory trends, and changing compliance requirements.

Responsibilities

• Prepare (write, analyze, and edit) and execute regulatory submissions in a format consistent with applicable guidance documents to the authority (Ministry of Health, NADFC/BPOM(Indonesian FDA), Ministry of Law and Human Rights, and other foresees in the future)
• Lead negotiations with health authorities during development, registration, and product lifecycle activities to resolve regulatory issues/negotiate approvals and proactively report the status to direct superior and Country Head or key internal stakeholders.
• Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
• Assist in communicating enquiries, feedbacks, and any related updates in related to product listing process to organization, as well as assisting in providing respond to authority.
• Act as Company Responsible Pharmacist if required.
• Corporate Drug Safety & Pharmacovigilance: support to conduct pharmacovigilance activities, ensure timely submissions, and maintain safety documentation.

Job description

Fresenius Medical Care is hiring for a Regulatory Affairs Manager in Bekasi, Indonesia. You will manage regulatory compliance, prepare submissions, maintain licenses, and oversee pharmacovigilance activities to support product approvals and lifecycle management.

The role requires close collaboration with internal teams and regulators to ensure adherence to local and global standards, and to drive timely regulatory responses and labeling reviews across products.