Deskripsi pekerjaan
Posisi Regulatory Affairs bertanggung jawab untuk mengelola registrasi produk biofarmasi di BPOM. Peran ini bertindak sebagai penghubung utama antara perusahaan dan otoritas regulasi, memastikan seluruh aktivitas perusahaan mematuhi peraturan BPOM, Kementerian Kesehatan, dan regulasi lokal lainnya.
Tanggung jawab: Manage product registration, re-registration, and variations for biopharmaceutical products with BPOM; Prepare, compile, review, and submit regulatory dossiers; Ensure regulatory compliance with BPOM and Ministry of Health; Monitor regulatory changes and conduct gap analysis; Act as main contact person for regulatory authorities; Manage regulatory aspects of product changes (change control); Review and approve product labeling and promotional materials.
Tanggung jawab
- Manage product registration, re-registration, and variations for biopharmaceutical products with BPOM
- Prepare, compile, review, and submit regulatory dossiers
- Ensure regulatory compliance with BPOM and Ministry of Health
- Monitor regulatory changes and conduct gap analysis
- Act as main contact person for regulatory authorities
- Manage regulatory aspects of product changes (change control)
- Review and approve product labeling and promotional materials
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Gaji
- Rp 7.500.000 – Rp 11.000.000 per month