Regulatory Officer

6 days ago

Jakarta, Jakarta, Indonesia PT. Emaklon Digital Internasional Full time 4,000,000 - 6,000,000 per year

Kualifikasi :

  • Pendidikan minimal S1 Farmasi, Kimia, Biologi, Teknologi Pangan, atau bidang terkait.
  • Memahami peraturan dan pedoman registrasi produk (BPOM, Kemenkes, ISO, Halal, dll).
  • Memahami regulasi dan pendaftaran BPOM, CPKB, dan prosedur notifikasi kosmetik.
  • Memiliki kemampuan dokumentasi dan administrasi yang baik.
  • Teliti, komunikatif, dan mampu bekerja sama lintas departemen.
  • Pengalaman di bidang regulatory menjadi nilai tambah (biasanya 1–3 tahun untuk level officer)

Tugas dan Tanggung Jawab Utama :

  • Menyiapkan dan mengurus perizinan produk ke instansi pemerintah terkait (misalnya BPOM, Kemenkes, Kemendag, dan instansi lainnya).
  • Memastikan kepatuhan regulasi terhadap semua produk, bahan, label, klaim, dan iklan sesuai peraturan yang berlaku.
  • Mengelola dokumen registrasi produk, termasuk dossier, formula, COA, MSDS, dan dokumen pendukung lainnya.
  • Melakukan komunikasi dan koordinasi dengan instansi pemerintah serta lembaga sertifikasi untuk proses registrasi atau perpanjangan izin.
  • Memantau perubahan regulasi dan memberikan update serta rekomendasi kepada manajemen terkait dampak terhadap produk/perusahaan.
  • Mendukung audit internal dan eksternal yang berhubungan dengan aspek regulatori.
  • Berkoordinasi dengan departemen R&D, QA, dan Marketing untuk memastikan semua proses dan materi sesuai ketentuan regulasi.

Jenis Pekerjaan: Penuh Waktu

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