We are looking for remote regulatory support in South Korea. The person needs to be based in KR with a KR cell phone number to access client virtual environment & interact with Ministry of Food and Drug Safety.

Work is fully home based with no travel required. The project begins ASAP and ends 31^st July 2023.

It concerns 0. 5 FTE (note that 1 FTE is 1800 billable (operational) hours per year (excluding vacation time, bank holidays, sick leave). 

Job description (see attachment for more detail):

Lifecycle Maintenance activities for 7+ medicinal products (woman health & general medicines):

• Interactions with Korean Health authorities MFDS behalf of our client for dedicated products
• Regulatory frameworks and strategy for lifecycle management. Including all types of variations, additional indication, renewal and MAH change. In case a change in an NDA this is in scope.
• Dossier preparation and submission of hard copy paper and electronic
• Product claims / labelling
• Information communication in relation to regulatory strategy and submission
• Translation activities
• Advertising and promotion
• MAH withdrawal
• Post approval maintenance and reporting
• PV related document
• Invoice check
• Archiving
• Regulatory intelligence
• Cross-functional communication scientific issues
• Critical issue management
• LQSD/LSRP
• Support and response to request form
• and others

Qualification profile:

Pharmacist preferred but BSC or MSc with 2-5 years experience in Pharma industry or health authorities

How to apply:

Please send CV and LinkedIn profile to helene.deconinck@pharmalex.com