Regulatory Affairs & Pharmacovigilance Lead

Pengiklan Anonim; Tangerang; On-site; IDR 334,800,000 - 669,600,000; Full time

Job summary

Fresenius Medical Care Indonesia is seeking a Regulatory Affairs Manager to lead regulatory compliance and submissions to Indonesian health authorities, maintain licenses and product registrations, and ensure adherence to local and global drug safety standards.

Responsibilities include monitoring adverse events, supporting audits, managing product labeling and promotional materials, and acting as Deputy Qualified Pharmacovigilance Responsible Person, in close collaboration with internal teams

Qualifications

• Bachelor's degree in pharmacy or related field and licensed in Indonesia.
• Experience in regulatory affairs, pharmacovigilance, and submissions.
• Knowledge of local and international drug safety standards.

Responsibilities

• Lead regulatory submissions to Indonesian health authorities with timely responses.
• Maintain licenses and product registrations, ensuring compliance.
• Monitor adverse events and support pharmacovigilance activities.
• Review labels and promotional materials for regulatory compliance.
• Collaborate with internal teams and regulators to support approvals and lifecycle management.

Skills

Regulatory submissions

Pharmacovigilance

Regulatory compliance

Regulatory strategy

Documentation management

Liaison with authorities

Education

Pharmacist degree

Tools

Regulatory databases

Job description

Fresenius Medical Care Indonesia is seeking a Regulatory Affairs Manager to lead regulatory compliance and submissions to Indonesian health authorities, maintain licenses and product registrations, and ensure adherence to local and global drug safety standards.

Responsibilities include monitoring adverse events, supporting audits, managing product labeling and promotional materials, and acting as Deputy Qualified Pharmacovigilance Responsible Person, in close collaboration with internal teams