Regulatory Affairs Manager — Submissions & Pharmacovigilance

Siloam Hospitals Group (Tbk); Jawa Barat; On-site; IDR 400,000,000 - 800,000,000; Full time

Job summary

Fresenius Medical Care is seeking a Regulatory Affairs Manager to lead regulatory submissions, maintain licenses, and ensure compliance with Indonesian and global standards. You will collaborate with internal teams and regulators to support product approvals, lifecycle management, and pharmacovigilance.

The role requires 8–10 years in regulatory affairs, deep knowledge of pharma and medical device regulations, and strong project management.

Qualifications

• Minimum 8–10 years of progressive Regulatory Affairs experience in pharma or medical devices.
• Deep knowledge of local regulations, registrations, and lifecycle management.
• Ability to influence senior stakeholders and provide regulatory guidance.
• Strong project management and regulatory intelligence skills.
• Commitment to patient safety, product quality, and regulatory excellence.

Responsibilities

• Prepare regulatory submissions and annual reports to authorities.
• Maintain regulatory files and licenses; ensure timely renewals and registrations.
• Lead negotiations with health authorities during development and lifecycle activities.
• Oversee pharmacovigilance operations and reporting to authorities.
• Review labeling and promotional materials for regulatory compliance.

Skills

Regulatory strategy

Stakeholder influence

Pharmacovigilance

Lifecycle management

Regulatory compliance

Job description

Fresenius Medical Care is seeking a Regulatory Affairs Manager to lead regulatory submissions, maintain licenses, and ensure compliance with Indonesian and global standards. You will collaborate with internal teams and regulators to support product approvals, lifecycle management, and pharmacovigilance.

The role requires 8–10 years in regulatory affairs, deep knowledge of pharma and medical device regulations, and strong project management.