Senior Regulatory Affairs Specialist – BPOM Biopharma

PT SKPLASMA CORE INDONESIA; Jakarta Utara; On-site; IDR 167,400,000 - 290,160,000; Full time

Job summary

PT SKPLASMA CORE INDONESIA, part of SK Group, seeks an experienced regulatory affairs specialist to manage BPOM registrations, re-registrations, and variations for biopharmaceutical products. You will be the main regulator liaison, preparing dossiers and ensuring compliance across BPOM, Ministry of Health, and related local authorities.

The role involves cross-functional collaboration with QA, QC, Manufacturing, and R&D, handling change controls, post-approval commitments, and timely submissions

Qualifications

• Bachelor's degree in Pharmacy, and registered pharmacist preferred.
• 3–5+ years of experience in pharmaceutical/regulatory affairs (Specialist/Senior level).
• Strong BPOM/regulatory knowledge and cross-functional collaboration.

Responsibilities

• Manage BPOM registrations, re-registrations, and variations.
• Prepare, compile, review, and submit regulatory dossiers.

Education

Bachelor's degree in Pharmacy

Registered Pharmacist (Apoteker)

Biology/Biotechnology degrees may be considered

Job description

PT SKPLASMA CORE INDONESIA, part of SK Group, seeks an experienced regulatory affairs specialist to manage BPOM registrations, re-registrations, and variations for biopharmaceutical products. You will be the main regulator liaison, preparing dossiers and ensuring compliance across BPOM, Ministry of Health, and related local authorities.

The role involves cross-functional collaboration with QA, QC, Manufacturing, and R&D, handling change controls, post-approval commitments, and timely submissions