Regulatory Affairs Specialist — Pharma Compliance

PT Gidion Jaya; Sidoarjo; On-site; IDR 89,280,000 - 156,240,000; Full time

Job summary

PT Gidion Jaya invites applications for a Regulatory Affairs role focused on Indonesian KEMENKES registrations and compliance. You will handle pre-registration dossiers, submissions, and post-registration reporting, ensuring alignment with regulatory changes.

Based in Surabaya/Sidoarjo, candidates with pharma degrees and regulatory knowledge are preferred. English proficiency is required; fresh graduates with strong regulatory background are welcome.

Qualifications

• Fluent in English to understand regulations and write responses.
• Detail-oriented and able to meet deadlines.
• D3 Pharmacy or S1 Pharmacy degree.
• Fresh graduates welcome with strong regulatory background.
• Familiar with ISO or FDA/CE regulatory regimes.

Responsibilities

• Register ijin PBF, PAK, CDOB, CDAKB, NIE with KEMENKES.
• Prepare technical dossiers, artwork, and marketing materials.
• Manage submissions, corrections, and responses to KEMENKES.
• Assist import activities to ensure regulatory conformity.
• Liaise with stakeholders and support reporting duties.

Skills

English proficiency

Regulatory documentation

Deadline-oriented

Independent worker

Education

D3 Farmasi / S1 Farmasi

Tools

ISO familiarity

Job description

PT Gidion Jaya invites applications for a Regulatory Affairs role focused on Indonesian KEMENKES registrations and compliance. You will handle pre-registration dossiers, submissions, and post-registration reporting, ensuring alignment with regulatory changes.

Based in Surabaya/Sidoarjo, candidates with pharma degrees and regulatory knowledge are preferred. English proficiency is required; fresh graduates with strong regulatory background are welcome.