Regulatory Affairs Assistant Specialist

3 months ago


Bandung, Indonesia PT Dexa Medica Full time

Regulatory Affairs Assistant Specialist berperan penting dalam memastikan kepatuhan terhadap persyaratan peraturan dan berkontribusi terhadap keberhasilan produk Dexa. Posisi ini bertanggung jawab untuk memastikan diperolehnya ijin edar produk dari BPOM melaui pengelolaan dokumen dan proses registrasi.
- Menyiapkan, menyerahkan, mengelola dan mengajukan dokumen registrasi produk sesuai peraturan dalam rangka perpanjangan ijin edar maupun untuk produk baru
- Berkolaborasi dengan antar departemen untuk memastikan bahwa produk memenuhi standar dan persyaratan peraturan
- Bekerjasama dengan berbagai departemen untuk memfasilitasi dan menjawab pertanyaan atau permintaan informasi dari BPOM
- Memastikan persetujuan ijin edar diperoleh secara tepat waktu
- Memberikan masukan strategi pengembangan produk berdasarkan persyaratan dan peraturan yang berlaku
- Sosialisasi informasi peraturan kepada tim internal dan mitra eksternal
- Lulusan Profesi Apoteker
- Berpengalaman mínimal 1 tahun di bidang registrasi produk
- Lulusan baru dipersilahkan melamar
- Memiliki pengetahuan dasar terkait industri farmasi dan produk farmasi
- Menguasai bahasa inggris (pasif)
- Lokasi penempatan: Head Office, Titan Center Bintaro

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"Please be aware of the Fraud Company. The company will never be collecting any payment in the process of interview. Please immediately report to us if there's any companies that collecting payment to the Jobseekers."



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