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PT Brighty Global Sinergi is seeking a Regulatory Specialist with a pharmacist background and active STRA to manage product registrations, licensing, and regulatory compliance for cosmetics, medical devices, and F&B products in Indonesia. The role requires strong knowledge of BPOM, Kemenkes, Halal, and related standards, plus team leadership and strategic planning abilities.
You will oversee pharmacy operations, regulatory audits, certifications, and liaise with regulatory bodies while
Minimum 3 years of experience as a Regulatory Specialist, preferably in cosmetics, pharmaceutical, medical devices, or FMCG.
Pharmacist with an active STRA.
Strong knowledge of BPOM, Kemenkes, Halal, CPOB, CPKB, and CDAKB regulations.
Strong analytical, problem-solving, and strategic planning skills.
Good communication and team leadership skills.
Experience in regulatory, quality management, and/or pharmaceutical operations is preferred.
Responsibilities
Manage product registration, licensing, and regulatory compliance for cosmetics, medical devices, and F&B products.
Ensure compliance with BPOM, Kemenkes, Halal, CPKB, CDAKB, CPOB, and relevant ISO standards.
Oversee pharmacy operations, inventory, procurement, dispensing, and product counseling.
Lead regulatory audits, inspections, and CAPA implementation.
Maintain and renew company certifications and licenses.
Coordinate with BPOM, Kemenkes, BPJPH, certification bodies, and internal stakeholders.
Support new product launches, review marketing claims, and provide product/regulatory training to commercial teams.
Develop and maintain SOPs, quality documentation, and regulatory reports.