Deskripsi Pekerjaan
Are you a detail-oriented professional with a passion for regulatory compliance and legal affairs? Bintang Kencana Anugrah is currently seeking a highly skilled Regulatory Affairs Specialist to join our dynamic team in Malang. In this role, you will be the backbone of our operational compliance, ensuring that all business activities strictly adhere to local and national regulations.
We are looking for an expert who understands the intricacies of the Indonesian regulatory landscape. You will play a pivotal role in managing product registrations, maintaining corporate compliance, and serving as a liaison between our company and government agencies. If you thrive in a fast-paced environment and possess deep knowledge of OSS, Siinas, and NIE processes, we want to hear from you.
Join a growing company where your expertise in DCC control and legal documentation will directly influence our ability to scale and succeed in the marketplace. We offer a collaborative work culture, professional growth opportunities, and the chance to take full ownership of our regulatory workflow.
Tanggung Jawab
- Manage end-to-end product registration processes, including securing Nomor Izin Edar (NIE).
- Operate and maintain compliance within the Online Single Submission (OSS) and Siinas systems.
- Oversee Document Control Center (DCC) activities to ensure all legal and operational documentation is current and compliant.
- Serve as the primary point of contact for external audits and government regulatory inquiries.
- Monitor changes in regulatory legislation and advise management on necessary operational adjustments.
- Maintain and organize comprehensive digital and physical files for all permits, licenses, and legal certificates.
- Coordinate with internal departments to ensure production and distribution activities align with registered technical specifications.
Kualifikasi
- Bachelor’s degree in Law, Pharmacy, Food Technology, or a related field.
- Minimum 2-3 years of proven experience in Regulatory Affairs or Corporate Legal compliance.
- In-depth technical knowledge and hands-on experience using the OSS and Siinas platforms is mandatory.
- Experience in securing NIE (Izin Edar) for consumer or industrial products is highly preferred.
- Strong understanding of Document Control (DCC) and archival best practices.
- Excellent analytical, communication, and interpersonal skills with the ability to negotiate with government officials.
- High level of integrity, attention to detail, and ability to manage multiple regulatory deadlines effectively.