Regulatory Affairs Specialist: Submissions & Compliance

Pt Putragaya Wahana; Jakarta Pusat; On-site; IDR 900,000,000 - 1,500,000,000; Full time

Job summary

Fresenius Medical Care is seeking a Regulatory Affairs Manager to oversee regulatory compliance, submissions, and lifecycle management for our Indonesia-related products. The role requires collaboration with health authorities and internal teams to ensure patient safety and regulatory excellence.

The position involves managing regulatory filings, labeling reviews, and audits, while ensuring adherence to global and local requirements.

Qualifications

• 8–10 years of progressive Regulatory Affairs experience in pharma, medical devices, or healthcare.
• Deep knowledge of local and global regulatory requirements and lifecycle management.
• Proven ability to influence senior stakeholders and guide leadership teams.
• Experience coordinating submissions, audits, labeling reviews, and compliance activities.
• Strong regulatory intelligence, risk assessment, and cross-functional collaboration.
• Experience establishing regulatory systems, databases, and governance frameworks.
• Excellent organizational skills, attention to detail, and integrity.

Responsibilities

• Lead regulatory submissions for registrations, variations, and renewals with authorities.
• Maintain licenses, registrations, device listings, and ensure compliance with regulations.
• Oversee pharmacovigilance activities and report safety information as required.
• Support external regulatory audits and provide regulatory input to minimize findings.
• Review labels, marketing materials, and ensure regulatory compliance.
• Coordinate cross-functional teams and communicate regulatory updates to stakeholders.
• Act as Company Responsible Pharmacist if required and manage regulatory contacts.

Skills

Regulatory strategy

Lifecycle management

Stakeholder management

Pharmacovigilance oversight

Regulatory intelligence

Regulatory negotiations

Regulatory inspections/audits

Attention to detail

Job description

Fresenius Medical Care is seeking a Regulatory Affairs Manager to oversee regulatory compliance, submissions, and lifecycle management for our Indonesia-related products. The role requires collaboration with health authorities and internal teams to ensure patient safety and regulatory excellence.

The position involves managing regulatory filings, labeling reviews, and audits, while ensuring adherence to global and local requirements.