SEOUL NATIONAL UNIVERSITY
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프랑스 제약회사 PharmaLex Product Lifecycle Management Consultant 채용

 
[PharmaLex Product Lifecycle Management Consultant]
 

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 31st 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

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