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Regulatory Affairs (Senior Officer / Assistant Manager)

NT Pharma (HK) Ltd

  • Company Industries:Medical / Pharmaceutical

Job Information

  • Post Date:2019-03-05
  • Career Level:Middle
  • Location:Wan Chai
  • Yr(s) of Exp:3 years
  • Qualification:Degree
  • Salary:Salary provided
  • Employment Type:Full Time, Permanent
  • Others:Full Time, Permanent
  • Job Function:Others  Pharmaceutical  

Job Description

Job Descriptions:

  1. To manage all regulatory issues related to the business scope of the Company
  2. To handle direct product registrations and the wholesale dealer’s license (Pharmaceuticals) with the authority in Hong Kong
  3. To liaise and support local business partners for maintaining the Company’s product licenses in individual countries
  4. To handle artwork design of the company products and connect these artworks to the manufacturer of the products.
  5. To plan and execute MA transfer plan of the new acquisition from the previous holder to the Company or its business partners according to commercial need and supply alignment.
  6. To work closely with supply chain to achieve optimization for present and future supply planning (SKU sharing, local redressing) to every international market.
  7. To connect/redirect QA and PV issues of individual countries to the relevant parties within the Company’s organization network, manufacturers, authorities and business partners.

 

Requirements:

  1. 3 years of regulatory affairs experiences in Hong Kong and / or Asia Pacific pharmaceutical markets.
  2. University Graduate in life-science related subjects
  3. Understanding of international standards in pharmaceutical industry such as GMP, GDP, PIC/S, ICH etc.
  4. Hands-on technical experience manipulating product package artwork documents (.ai; .pdf)  and using related software, such as Illustrator or Acrobat.
  5. Project management skill is desired
  6. Working under minimal supervision
  7. Minimal travel to various overseas countries is required

 

Company Info

This is a newly created position to be stationed in Hong Kong. The cumbent is responsible to manage all regulatory issues related to a recent acquisition of an osteoporosis prescription product which has been supplied from Switzerland to more than 20 countries globally.  On the other hand, registration of the company’s current products in Hong Kong and other international markets is also the major objective of the position. This is a highly exposed role working in a cross-cultural matrix of internal and external stakeholders. 

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