Lowongan Kerja Jakarta Selatan Posisi Regulatory Manager di PT Eisai Indonesia

Info Loker

Perusahaan	PT Eisai Indonesia
Posisi	Regulatory Manager
Tempat	Jakarta Selatan
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Penelitian Klinis/Medis (Kesehatan & Medis)
Gaji Min	Rp. 1.800.000
Gaji Max	Rp. 5.500.000

Main Responsibilities : 

• Review the eligibility of the registration document that received from principal then give feedback to them to ensure that all of documents have met requirements in Indonesia. 
• Review and ensure registration documents are in accordance with BPOM requirements in the form of ACTR / ACTD (ASEAN Common Technical Requirements / ASEAN Common Technical Dossier) or ICH-CTD (International Conference on Harmonization-Common Technical Dossier).
• Ensuring that all of product target (new product, renewal and variation registration) be submitted to BPOM.
• Collaboration with Medical Team for discussion with Pharmacologist to get input regarding efficacy and safety data especially before (KOMNAS) Meeting.
• Coordination with PD & Logistic Person regarding packaging material, production & importation preparation (for local & import products) so that launching & implementation of variation can be on schedule & fulfil the regulation.
• Keep good relationship with BPOM.

Position Requirements : 

• Pharmacist with experience min. 5 years in similar fields
• Mastering registration process in BPOM
• Good understanding in ACTR / ACTD, GMP, and GCP
• Have experience in managing team will be good advantage
• Able to communicate in English (Verbal and Written)

Lamar kerja

Deskripsi Perusahaan

Info Perusahaan

• Industri: BioTeknologi/Farmasi/Riset klinik
• Ukuran Perusahaan: 201 - 500 pekerja
• Waktu Proses Lamaran: 25 hari
• Tunjangan dan Lain-lain: Asuransi Gigi, Tip, Asuransi kesehatan, Penglihatan, Waktu regular, Senin - Jumat, Bisnis (contoh: Kemeja)