Deskripsi Pekerjaan
Are you a detail-oriented professional with a passion for compliance and regulatory excellence? PT Biomedikal Indopharm Nusantara is seeking a dedicated Regulatory Officer to join our growing team in Curug, Banten. In this role, you will play a pivotal part in ensuring our pharmaceutical products and medical innovations meet all rigorous industry standards and governmental regulations.
We are specifically looking for an expert in the submission and management of TKDN (Tingkat Komponen Dalam Negeri) certifications. You will be the bridge between our production processes and regulatory bodies, ensuring seamless operations, timely documentation, and full adherence to Indonesian pharmaceutical laws. If you are highly organized, proactive, and eager to contribute to the healthcare innovation landscape, we would love to hear from you.
Tanggung Jawab
- Manage the end-to-end process of TKDN certification applications and renewals.
- Coordinate with internal departments to collect and verify technical documentation for product compliance.
- Liaise with government regulatory bodies and external auditors to resolve compliance queries.
- Monitor updates to pharmaceutical and medical device regulations to ensure company policies remain current.
- Prepare comprehensive regulatory reports and maintain accurate filing systems for all certifications.
- Identify potential compliance gaps and implement corrective actions to improve regulatory standing.
Kualifikasi
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field.
- Proven experience as a Regulatory Officer or in a similar compliance role within the pharmaceutical/medical device industry.
- Deep understanding of TKDN certification processes and relevant government regulations.
- Strong analytical skills with a high level of attention to detail and data integrity.
- Excellent communication skills in Bahasa Indonesia and professional proficiency in English.
- Ability to manage multiple project timelines simultaneously and work under regulatory deadlines.
- Proficiency in Microsoft Office Suite and document management software.