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