Regulatory Staff BPOM
1 week ago
- Pendidikan minimal S1 Farmasi (diutamakan Apoteker), Biologi, Kimia, Gizi, atau jurusan relevan.
- Pengalaman minimal 2 tahun di bidang Regulatory Affairs terkait BPOM. (Sangat diutamakan)
- WAJIB Memahami proses registrasi BPOM (e-Registration/e-Notifikasi).
- Mampu mengelola dokumen secara rapi dan teliti.
- Komunikatif dan mampu bekerja sama dengan tim lintas divisi.
- Terbiasa menggunakan sistem online BPOM dan Microsoft Office.
Tanggung Jawab Utama:
Registrasi Produk ke BPOM:
Mengelola seluruh proses registrasi dan/atau notifikasi produk sesuai dengan kategori (kosmetik, makanan/minuman, suplemen, obat, atau bahan baku).
Menyiapkan dan mengunggah dokumen registrasi melalui sistem e-Registration BPOM.
Memastikan kelengkapan dan keakuratan seluruh dokumen pendukung seperti MSDS, COA, LoA, hasil uji laboratorium, dan label produk.
Pemantauan Status Perizinan:
Memantau perkembangan proses perizinan di sistem BPOM.
Mengikuti komunikasi dengan BPOM terkait status atau revisi dokumen.
Menindaklanjuti secara aktif hingga izin edar atau notifikasi diterbitkan.
Pengelolaan Dokumen Regulasi:
Membuat, menyusun, dan mengarsipkan seluruh dokumen registrasi sesuai dengan standar Good Documentation Practices.
Memastikan seluruh dokumen selalu tersedia dalam format terkini dan siap audit.
Audit & Kepatuhan Regulasi:
Mendukung proses audit internal maupun eksternal, termasuk BPOM inspection.
Memastikan seluruh produk dan aktivitas perusahaan sesuai dengan peraturan yang berlaku dari BPOM, Kementerian Kesehatan, dan lembaga terkait lainnya.
Melakukan pembaruan izin dan notifikasi jika ada perubahan formulasi, label, atau kemasan.
Koordinasi Lintas Departemen:
Berkoordinasi dengan departemen R&D, Produksi, QC/QA, dan Marketing untuk pengumpulan informasi teknis dan label klaim produk.
Memberikan panduan kepada tim internal terkait perubahan regulasi atau kebijakan dari otoritas pemerintah.
Pemantauan Perubahan Regulasi:
Secara aktif mengikuti dan mempelajari perubahan atau pembaruan regulasi dari BPOM dan lembaga pengawas lainnya.
Memberikan rekomendasi kepada manajemen atas dampak regulasi terhadap portofolio produk.
Pelaporan & Komunikasi:
Membuat laporan berkala terkait status registrasi dan izin edar produk.
Menjaga komunikasi profesional dengan BPOM dan instansi pemerintah lainnya sebagai perwakilan resmi perusahaan.
Lokasi Kerja:
Lippo St. Moritz Office Tower, Lt. 19 Unit 1902, Jl. Puri Indah Raya, RT.3/RW.6, Kembangan Sel., Kec. Kembangan, Kota Jakarta Barat, Daerah Khusus Ibukota Jakarta 11610
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