Regulatory Affairs Officer

Job Description:

• Conduct registration of medical devices, cosmetics, health supplements, household health supplies (PKRT), pesticides, and/or pharmaceuticals to the relevant authorities.
• Review documents related to product registration processes to ensure compliance with applicable regulations.
• Prepare and compile documents required for product registration submission to authorities.
• Liaise and consult with regulatory authorities regarding product registration procedures and requirements.
• Communicate and coordinate (both in writing and verbally) with manufacturers and other related parties to collect necessary documentation for product registration.
• Monitor and follow up on registration submissions until product distribution licenses are issued.
• Develop tracking systems and maintain databases or other records related to product registration processes.

Requirements:

• Bachelor's degree in Pharmacy / Apothecary.
• Minimum 1–2 years of experience in Regulatory Affairs (fresh graduates with relevant internship experience are welcome to apply).
• Familiar with BPOM, Kemenkes, and other relevant regulatory submission processes.
• Strong attention to detail and ability to manage documentation accurately.
• Good communication and coordination skills with internal and external stakeholders.
• Proficient in Microsoft Office (Excel, Word, PowerPoint).
• Good command of English (both written and spoken) is an advantage.
• Highly organized, proactive, and able to work under tight deadlines.