Lowongan Kerja Jakarta Raya Posisi Regulatory Affairs Manager – Global Biotechnology Company di PT Michael Page Internasional Indonesia

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Perusahaan	PT Michael Page Internasional Indonesia
Posisi	Regulatory Affairs Manager - Global Biotechnology Company
Tempat	Jakarta Raya
Tingkatan Kerja	Manajer/Asisten Manajer
Kualifikasi	Diploma Pascasarjana, Gelar Professional, Magister (S2), Sarjana (S1)
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Bioteknologi, Sains
Gaji Min	Rp. 1.800.000
Gaji Max	Rp. 5.500.000

• Responsible to obtain Marketing Authorization and ensure regulatory compliance
• Responsible for all regulatory documents and process to governments

Client Details

Our Client is a well-established Asian pharma company, that is expanding to countries all over Asia. They focus on innovative products with best efficacy-in-class, as well as leading market position in their country of origin. They have over 30 innovative products, some are registered in the U.S and Europe. They are currently branching out to Indonesia, and looking for Regulatory Affairs Manager

Description

• Obtain Marketing Authorization for national first-in-class products
• Manage compilation of dossier, and compliance to ICH or local technical dossier format
• Ensure regularity compliance through life cycle management and license renewals
• Manage company regulatory affairs activities including reports, license transfers and renewals to ensure compliance with government requirements and company standards
• Develop regulatory strategies in line with business objectives
• Liaise with supply chain to ensure compliance of product label in commercial shipment
• Liaise with company functions (Production, R&D, QA) as well as external agencies to carry regulatory operation
• Compile regional periodic safety updates reports

Profile

• Bachelor degree from pharmacy / science background
• Minimum 5 years experience in RA settings (>10 years preferred)
• Experience in pharmaceutical company (handling medical device and quality is a plus)
• Experience in registering national or global first-in-class product is preferred
• Good relationship with country health authorities (MoH and NADFC) is a plus
• Proficient in oral and written English. Mandarin is a plus

Job Offer

• Opportunity to establish innovative products in newly-established country
• Chance to build and lead regulatory affair team
• Competitive salary

To apply online please click the ‘Apply’ button below.

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Deskripsi Perusahaan

Info Perusahaan

• Industri: Manajemen/Konsulting HR
• Ukuran Perusahaan: 51 - 200 pekerja
• Lokasi: Jakarta Raya, Jawa Barat