Description of Regulatory Affairs - PT Sixmurs Perdana
Job Description
1. Handle the registration of medical devices, cosmetics, health supplements, household health supplies (PKRT), pesticides, and/or pharmaceuticals with the relevant regulatory authorities.
2. Review and verify documentation to ensure compliance with applicable regulations during the product registration process.
3. Prepare and compile regulatory dossiers and required supporting documents for submission.
4. Conduct consultations with regulatory authorities to clarify and ensure compliance with registration requirements.
5. Communicate and coordinate (in writing and in person) with manufacturers and other stakeholders to gather necessary documentation.
6. Monitor the status of product registration submissions until distribution licenses are obtained.
7. Create and maintain tracking systems and reports to support the registration process and ensure timely submissions.
Requirements
1. Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field (required).
2. Minimum 1–3 years of experience in regulatory affairs or product registration (experience in medical devices, cosmetics, or pharmaceuticals is a plus).
3. Familiarity with local regulatory requirements (e.g., BPOM, KEMENKES, etc.) and product registration processes.
4. Strong attention to detail and ability to review technical documentation thoroughly.
5. Good communication and interpersonal skills to coordinate with internal teams, manufacturers, and regulatory bodies.
6. Proficient in Microsoft Office (Excel, Word, PowerPoint) and comfortable working with tracking or reporting tools.
7. Able to manage multiple registration projects simultaneously and meet deadlines.
Job Details
1. Placement Location : Kelapa Gading, Jakarta Utara.
2. Industry : Healthcare.
3. Employment Period : Full Time.
