Regulatory Assistant Specialist

2 weeks ago


Tangerang, Banten, Indonesia Dexa Group Full time
Description

Mengelola dokumen registrasi produk dan proses submission sesuai ketentuan regulator, memantau progres pengajuan, berkoordinasi untuk kelengkapan dokumen, serta menjaga database dan arsip regulatori agar selalu akurat dan siap audit.

Responsibilities
  • Menyiapkan, meninjau, dan mengelola dokumen registrasi produk sesuai ketentuan otoritas regulatori setempat (lokal maupun overseas)
  • Mendukung proses submission untuk registrasi baru, perubahan, dan perpanjangan melalui sistem otoritas regulatori.
  • Memantau progres pengajuan dan melakukan tindak lanjut untuk memastikan timeline terpenuhi serta memberikan update kepada pemangku kepentingan internal.
  • Berkoordinasi dengan tim internal dan pihak eksternal untuk pengumpulan dan verifikasi dokumen teknis.
  • Memelihara database dan arsip dokumen regulatori agar akurat, lengkap, dan siap untuk kebutuhan audit.
Qualifications
  • Profesi Apoteker
  • Berpengalaman 1–2 tahun di bidang Regulatory Affairs diutamakan
  • Fresh graduate dipersilakan melamar
  • Memahami dasar-dasar persyaratan regulatori dan proses registrasi produk lokal maupun overseas
  • Memiliki kemampuan Bahasa Indonesia & Bahasa Inggris yang baik


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