Job description for Regulatory Supervisor at PT Orson Indonesia
The Regulatory Supervisor is responsible for managing the company's regulatory affairs to ensure all cosmetic products, manufacturing activities, and regulatory documentation comply with applicable BPOM regulations, CPKB, GMP, QMS ISO 9001:2015, and other relevant legal requirements. The role ensures timely product registration, regulatory compliance, and effective coordination with internal and external stakeholders to support business continuity.
JOB DESCRIPTION:
1. Product Registration & Regulatory Submission
- Manage the registration, renewal, variation, and maintenance of cosmetic product notifications with BPOM.
- Prepare, review, and submit regulatory dossiers and supporting documents in accordance with applicable regulations.
- Monitor registration timelines to ensure products are approved and remain commercially available.
2. Regulatory Compliance & Licensing
- Monitor changes in BPOM regulations, GMP, CPKB, and other applicable regulatory requirements, and ensure timely implementation.
- Ensure all company licenses, certifications, and regulatory documents remain valid and up to date.
- Provide regulatory guidance to cross-functional teams during new product development, product changes, and commercialization.
3. Documentation & Audit Management
- Maintain accurate regulatory documentation, product technical files, and document control in accordance with ISO 9001 requirements.
- Prepare regulatory documents and evidence required during BPOM inspections, customer audits, and certification audits.
- Coordinate corrective and preventive actions (CAPA) related to regulatory findings and monitor their completion.
4. Cross-Functional Regulatory Support
- Collaborate with R&D, QA, Production, Purchasing, Marketing, and Sales to ensure products comply with regulatory requirements throughout their lifecycle.
- Review product claims, labels, packaging artwork, and promotional materials to ensure regulatory compliance before product release.
- Provide regulatory training and technical support to relevant departments.
- And any tasks and responsibilities given by the Company.
JOB REQUIREMENTS:
- Bachelor's Degree (S1) in Pharmacy, Chemistry, Chemical Engineering, Biology, Cosmetic Science, or other relevant Life Science disciplines.
- Minimum 5 years of experience in Regulatory Affairs, with at least 2 years in a supervisory role, preferably in the cosmetic, pharmaceutical, personal care, or FMCG manufacturing industry.
- Strong knowledge of BPOM cosmetic regulations, cosmetic product notification, product registration, labeling requirements, ingredient regulations, and post-market compliance.
- Comprehensive understanding of ISO 9001:2015, GMP, CPKB and BPOM regulations, including document control, audit management, CAPA, change control, and risk-based quality management.
- Experienced in preparing regulatory dossiers, technical documentation, and supporting BPOM inspections, certification audits, and customer audits.
- Proficient in Microsoft Office and regulatory documentation systems, with strong analytical, documentation, and project management skills.