Job ref no.: CT3119080-01#6843

Specialist, Regulatory Affairs, North East & South East Asia

Fresenius Kabi Asia Pacific Limited

 

Responsiblities:

  • Adapt Global RA strategy and ensure compliance to internal and external regulatory processes and standards
  • Monitoring/Tracking RA changes, trends, handle RA intelligence, authority lobbying, adapt Global RA strategy
  • Coordinate training on RA and RA IT systems to country RAs
  • Coordinate regional RA/QA meetings
  • Involve in RA regional projects
  • Support any other special projects assigned by Supervisor

 

Requirements:

  • University graduate in Life Science/ Natural Science, Pharmaceuticals, Biotechnology, or Engineering. Registered Pharmacist is preferable.
  • At least 4 years experience in operational RA role in either regional or local function
  • Experienced in the Pharma/ Healthcare/ Medical Devices/ Biotech/ Biologics/ Food Industry with leading MNCs
  • Possessed proven expertise in handling pharma or medical device or nutrition and/or biosimilar portfolios
  • Good knowledge in regulatory landscape and requirements for Asia, preferably for EU and USA too
  • Knowledge of QM systems, ISO 9001, ISO13485, WHO cGxP, ICH guidelines and exposure to Biosimilars and/or IV Generics would be an advantageous
  • Profound knowledge of RA/QA impacted IT systems
  • Accurate, well-organized and with strong ownership
  • Proactive and result driven
  • Excellent coordination, communication as well as strong interpersonal skill and strong team spirit
  • High proficiency in verbal and written English
  • Good conceptual and presentation skills

 

We offer successful candidate an attractive remuneration package and excellent career prospects. Interested parties please send your resume, present and expected salary by clicking Apply Now

 

 

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More job information
Job ref no. CT3119080-01#6843
Salary
  • N/A
Job Function
Industry
Employment Term
  • Full-time
Experience
  • 4 years - 9 years
Career Level
  • Non-management level
Education
  • Degree