Regulatory

6 days ago

Jakarta, Jakarta, Indonesia PT EMAKLON DIGITAL INTERNASIONAL Full time 6,000,000 - 8,000,000 per year

Job Description:

Regulatory Officer / Regulatory Affairs

  1. 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.

⸻

  1. Kualifikasi Umum


• Pendidikan minimal S1 Farmasi, Kimia, Biologi, Teknologi Pangan, atau bidang terkait.


• Memahami peraturan dan pedoman registrasi produk (BPOM, Kemenkes, ISO, Halal, dll).


• 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).


• Berpengalaman dibidang Kosmetik/skincare min 3 tahun: pendaftaran produk kosmetik, CPKB compliance.

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