Deskripsi Pekerjaan
Join Oneject as a Regulatory Affairs Officer and play a pivotal role in navigating Indonesia's complex regulatory landscape. We're seeking a dedicated professional to ensure our products meet all national compliance standards while supporting market expansion initiatives. In this dynamic position, you'll collaborate with cross-functional teams to develop regulatory strategies, prepare documentation submissions, and maintain compliance frameworks. Ideal candidates will bring expertise in Indonesian regulations (BPOM, Halal certification) and a passion for operational excellence. Oneject offers competitive benefits, professional development opportunities, and a collaborative work environment in Cikarang's thriving industrial hub. If you're detail-oriented, proactive, and committed to regulatory excellence, we invite you to contribute to our mission of delivering innovative solutions to market.
Tanggung Jawab
- Manage regulatory submissions for product approvals to Indonesian authorities (BPOM, Halal certification)
- Monitor and interpret regulatory changes affecting medical/pharmaceutical products
- Prepare and maintain technical documentation files (dossiers, labeling, PMAs)
- Coordinate with R&D and production teams to ensure regulatory compliance throughout product lifecycle
- Represent the company in regulatory audits and authority communications
- Develop and implement internal regulatory procedures and training programs
- Track regulatory approval timelines and ensure timely submissions
Kualifikasi
- Bachelor's degree in Pharmacy, Biology, Chemistry, or related scientific field
- 3+ years of regulatory affairs experience in medical devices or pharmaceuticals
- Deep knowledge of Indonesian regulatory framework (BPOM, Ministry of Health)
- Experience with product registration processes and documentation
- Strong analytical skills and attention to detail
- Proficient in Bahasa Indonesia and English (written and verbal)
- Certification in Regulatory Affairs (e.g., RAC) is advantageous