About the Company:
Talent Insider is an upcoming HR Consultancy Service, founded in 2021. Our clients have been some of the leading brands in Indonesia, and this service continues to expand.
Registered in Singapore & Indonesia, we can assist with your growth plans and strategies, and continue to expand our regional presence with strong regional partners to assist our client in recruitment and branding strategy.
Job 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
Job Requirements:
- 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
Skils:
Recruiter :
