Job description for Regulatory Affairs at PT Sinergi Harapan Sukses
What you'll be doing:
1. Act as the Responsible Technical Person (PJT) for cosmetic products.
2. Coordinate with principals (clients) to ensure the completeness and accuracy of documents required for product registration in Indonesia.
3. Review and compile the Product Information File (DIP) in accordance with current Indonesian regulations.
4. Liaise with relevant authorities (BPOM and Ministry of Health) throughout the product registration process.
5. Ensure the registration timeline is followed and completed according to the planned schedule.
What we’re looking for:
1. Bachelor’s degree in Pharmacy (Apothecary profession)
2. Must hold an active Apothecary (Pharmacist) license in Indonesia, including valid STRA (Surat Tanda Registrasi Apoteker) and SERKOM (Sertifikat Kompetensi), and must be willing to process SIPA (Surat Izin Praktik Apoteker).
3. Open to fresh graduates. Having experience in regulatory affairs—especially in the cosmetics, PKRT, or medical device industry—is a strong advantage.
4. Solid understanding of BPOM & KEMENKES regulations; knowledge of international regulations and halal certification is a plus.
5. Familiar with cosmetic product registration, label and claim compliance, and preparation of regulatory documentation.
6. Good communication skills in both Bahasa Indonesia and English, both written and spoken.
