Regulatory Affairs Specialist

• Prepare, compile, review, and submit pharmaceutical registration dossiers in ACTD/CTD format.
• Support new product registrations, renewals, variations, and post-approval regulatory activities.
• Track registration and renewal deadlines, submission status, and regulatory commitments.
• Support responses to BPOM queries, deficiency letters, and requests for additional information.
• Review product information, labelling, claims, and packaging materials for regulatory alignment.
• Support import-related regulatory documentation and coordinate with Quality, Supply Chain, EXIM, Medical, and Commercial teams.
• Maintain accurate regulatory databases, product files, submission records, and compliance documentation.

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related scientific field.
• 2–5 years of experience in regulatory affairs, product registration, quality assurance, or a related pharmaceutical function.
• Understanding of pharmaceutical dossier preparation, ACTD/CTD format, variations, renewals, and regulatory documentation.
• Strong attention to detail, document-management skills, and ability to manage multiple submissions.
• Good cross-functional communication and coordination skills.
• Fluent in Bahasa Indonesia and English; proficient in Microsoft Office.
• Apoteker certification and active STRA (preferred).
• Experience with BPOM drug registration, import licensing/SKI, imported products, halal certification, or regulatory authority correspondence (preferred).

• Compensation: Not disclosed

Fluent in Bahasa Indonesia, Fluent in English