Regulatory Affairs Lead | Global Submissions & PV

Pt Unitama Sari Mas; Jawa Barat; On-site; IDR 300,000,000 - 600,000,000; Full time

Job summary

Fresenius Medical Care seeks a Regulatory Affairs Manager to lead regulatory submissions and maintain registrations for Indonesia, ensuring compliance with local and international standards. You will coordinate labeling, adverse event monitoring, and support audits while partnering with cross-functional teams and regulators.

The role emphasizes maintaining licenses, managing product safety data, and driving lifecycle management to support business operations and timely product approvals.

Qualifications

• Regulatory affairs experience, especially submissions and registrations.
• Pharmacovigilance oversight and global/local regulatory compliance.
• Ability to collaborate with internal teams and external regulators.

Responsibilities

• Regulatory: prepare regulatory submissions, annual reports, and maintain regulatory files.
• Ensure products comply with medical device and drug regulations in relevant jurisdictions.
• Pharmacovigilance: oversee Pharmacovigilance Operations and ensure compliance with SOPs.

Job description

Fresenius Medical Care seeks a Regulatory Affairs Manager to lead regulatory submissions and maintain registrations for Indonesia, ensuring compliance with local and international standards. You will coordinate labeling, adverse event monitoring, and support audits while partnering with cross-functional teams and regulators.

The role emphasizes maintaining licenses, managing product safety data, and driving lifecycle management to support business operations and timely product approvals.