Prepare, compile, and submit product dossiers for BPOM (e-BPOM, ASROT, New-AERO), including technical documents, certificates, test reports, and administrative files.
Upload and manage all documents in the BPOM digital platforms.
Monitor application progress and respond promptly to BPOM evaluations, queries, and correction requests.
2. Manufacturer & Documentation Coordination
Liaise with Chinese manufacturers to obtain required documents such as GMP certificates, Certificate of Free Sale (CFS), Certificate of Analysis (CoA), specifications, raw material data, stability studies, and testing reports.
Ensure all foreign documents are complete, valid, translated, and legalized when required.
Review technical documentation for accuracy and compliance with Indonesian regulatory standards.
3. Regulatory Compliance & Label Control
Ensure that product formulas, claims, and packaging artwork fully comply with BPOM guidelines and Indonesian labeling regulations.
Review and approve marketing materials, ensuring claims remain scientifically valid and legally acceptable.
Conduct regulatory assessments for new ingredients, formulations, or product innovations.
4. Inspection & Regulatory Interactions
Manage BPOM inspections, audits, or remote evaluations related to imported products or foreign manufacturer GMP compliance.
Coordinate follow-up actions, corrective responses, and documentation for any BPOM findings.
Maintain strong professional relationships with regulatory authorities.
5. Post-Market Compliance
Monitor regulatory changes and ensure company products remain compliant with updated BPOM regulations.
Assist in post-market surveillance activities, including reporting of product quality issues or adverse events.
Maintain organized regulatory archives and records for all registered products.
QualificationsEducation & Experience
Bachelor's degree in Pharmacy (S.Farm, Apt preferred), Food Science, Chemistry, Biotechnology, or related fields.
Minimum 13 years of experience in Regulatory Affairs, specifically handling BPOM submissions.
Proven experience using e-BPOM, ASROT, and/or New-AERO platforms.
Familiarity with GMP, quality documentation, and international product registration requirements.
Technical Skills
Strong understanding of BPOM regulations for supplements, cosmetics, medical products, or OTC preparations.
Ability to review technical documents and scientific data.
Knowledge of product labeling regulations and claim limitations.
Soft Skills
Excellent communication skills in Bahasa Indonesia and English (Mandarin is a plus).
Strong attention to detail and analytical thinking.
Proactive and able to manage deadlines in a fast-paced environment.
Comfortable coordinating with cross-functional teams (QA, warehouse, logistics, marketing).
Work Arrangement
Position: Full-time
Reports to: Head of Regulatory Affairs / Operations Manager
Location: BSD, Tangerang Selatan (hybrid/flexible depending on company structure)
