Senior Regulatory Counsel & Pharmacovigilance Lead

Pt. Garena Indonesia; Jawa Barat; On-site; IDR 350,000,000 - 550,000,000; Full time

Job summary

Fresenius Medical Care is seeking a Regulatory Affairs Manager in Indonesia to manage regulatory compliance and submissions to the Indonesian health authorities, ensuring licenses and registrations are up to date and that labeling and promotional materials meet local and global standards.

The role requires close collaboration with internal teams and external regulators to support product approvals, lifecycle management, and overall business operations, including pharmacovigilance activities and

Qualifications

• Regulatory compliance and submissions to Indonesian health authorities.
• Maintain licenses and product registrations.
• Support product labeling and promotional materials; oversee pharmacovigilance activities.

Responsibilities

• Monitor adverse events and support audits.
• Collaborate with internal teams and regulators to obtain approvals.
• Lifecycle management and overall business operations support.

Job description

Fresenius Medical Care is seeking a Regulatory Affairs Manager in Indonesia to manage regulatory compliance and submissions to the Indonesian health authorities, ensuring licenses and registrations are up to date and that labeling and promotional materials meet local and global standards.

The role requires close collaboration with internal teams and external regulators to support product approvals, lifecycle management, and overall business operations, including pharmacovigilance activities and