Prepare, compile, and submit product registration dossiers to BPOM and other relevant regulatory authorities.
Manage end-to-end product registration activities, including new registrations, renewals, variations, and timely follow-up with regulatory agencies.
Conduct pre-registration assessments of product formulations, claims, packaging, and labeling to identify and mitigate regulatory risks before product launch.
Monitor and interpret updates to BPOM, ASEAN Cosmetic Directive (ACD), and other applicable regulatory requirements, and communicate their business impact to relevant stakeholders.
Provide regulatory guidance to cross-functional teams, including R&D, Product Innovation & Development, Marketing, and Supply Chain, on product compliance, ingredient permissibility, labeling, and claims.
Review product labels, packaging artwork, promotional materials, and digital marketing content to ensure compliance with applicable regulations.
Maintain accurate, organized, and audit-ready regulatory documentation in accordance with company SOPs and regulatory requirements.
Partner with internal stakeholders to support timely product launches while ensuring full regulatory compliance across the product lifecycle.
Requirements
Bachelor's degree (S1) in Pharmacy (Apoteker preferred), Chemistry, Chemical Engineering, Biology, or a related Life Sciences field.
Minimum 2–4 years of experience in Regulatory Affairs, preferably within the cosmetics, personal care, or beauty FMCG industry.
Strong knowledge on BPOM product registration processes (cosmetics, quasi-drugs, or OTC categories).
Exposure to ASEAN Cosmetic Directive (ACD) and international regulatory frameworks is an advantage.
