Regulatory Affairs Manager

• Manage drug registration with BPOM, including new registrations, variations, renewals and post-approval changes.
• Prepare and review registration dossiers (ACTD/CTD) and track renewal deadlines.
• Plan the regulatory approach for new product launches and keep the company updated on regulatory changes.
• Make sure product labels, claims and promotional materials follow regulations.
• Coordinate import permits (such as SKI) with the EXIM team for smooth Customs clearance.
• Build good working relationships with BPOM, Customs and other government agencies, and coordinate with halal certification bodies when needed.

• S1 in Pharmacy, Life Sciences, Chemistry or a related field., with 5+ years experience in regulatory affairs in the pharmaceutical industry.
• Proven experience in BPOM drug registration.
• Experience with import licensing and regulatory compliance.
• Strong knowledge of ACTD/CTD format.
• Good stakeholder management and communication skills.
• Fluent in Indonesian and English; proficient in Microsoft Office.
• Apoteker certification (Preferred).

• Compensation: Not disclosed

Indonesian (fluent), English (fluent)