Job description
PT Mastering Prima Abadi, a dynamic manufacturing company in Jakarta, is seeking a meticulous BPOM & Regulatory Compliance Specialist to ensure our products meet Indonesia's BPOM regulations and labeling standards. This role is critical to safeguard product quality, accelerate time-to-market, and maintain consumer trust across the product lifecycle.
As the BPOM & Regulatory Compliance Specialist, you will act as the primary regulatory liaison, translating complex rules into actionable plans for product development, quality assurance, packaging, and commercial teams. You will own regulatory submissions, manage registration renewals, and monitor regulatory changes to minimize risk and maximize compliance velocity.
Key responsibilities include collaborating with QA, Legal, Regulatory Affairs, and Supply Chain to implement compliant processes and maintain robust regulatory records. You will also facilitate BPOM inspections, prepare documentation for audits, and maintain up-to-date regulatory files to ensure readiness for internal or external reviews. This role offers opportunities to influence product strategy, strengthen internal controls, and contribute to a culture of compliance across the organization.
We welcome candidates who are proactive, data-driven, and fluent in Indonesian and English, with a demonstrated ability to communicate complex regulatory requirements across cross-functional teams.
Responsibility
- Manage and maintain BPOM registration dossiers for all products, including documentation accuracy, renewals, and post-market variations.
- Monitor Indonesian regulatory updates from BPOM and related agencies; assess impact and communicate changes to cross-functional teams.
- Prepare, submit, and track regulatory submissions to BPOM within agreed timelines (registrations, variations, and post-approval changes).
- Review and approve product labeling, packaging, and advertising to ensure compliance with BPOM guidelines and consumer protection rules.
- Coordinate with QA, QC, Legal, and Supply Chain to implement compliant processes and maintain robust regulatory records.
- Lead regulatory audits and inspections by BPOM, respond to findings, and implement corrective action plans.
- Provide training and guidance to internal teams on regulatory requirements and best practices for compliance.
Qualification
- Bachelor's degree in Pharmacy, Food Science, Public Health, or a related field.
- 3-5 years of experience in regulatory affairs within manufacturing or FMCG in Indonesia.
- Strong knowledge of BPOM regulations, circulars, and registration processes; proven experience with product registrations and changes.
- Familiarity with GMP/ISO quality systems and internal audits; excellent documentation skills.
- Excellent written and verbal communication in Indonesian and English; ability to interact effectively with regulatory authorities.
- Analytical mindset, attention to detail, and ability to manage multiple regulatory projects simultaneously.