Senior Regulatory Affairs Specialist


Our client in pharmaceutical and medical industry is expanding their regulatory affairs team to support regional RA projects.  They are seeking for a Senior Regulatory Affairs Specialist to join their team on Hong Kong.

Responsibilities:

  • Participation in local, regional and/ or global level in projects where regulatory input is required
  • Ensure Licenses for approved products are maintained and renewed on-time
  • Participate in coordinating RA training and RA/ QA meetings with overseas partners
  • Maintain oversight of the changing regulatory environment globally
  • Support any other special projects


Requirements:

  • University graduate in Life Science/ Pharmaceuticals, Biotechnology or Engineering.  Registered Pharmacist is preferable
  • At least 3- 4 years solid working experience in regulatory affairs (either regional or local)
  • Prior  experience in Pharma/ Healthcare/ Medical Device with MNCs would be a good advantage
  • Knowledge of QM systems, ISO 9001, IO13485, WHO cGxP
  • Good knowledge in regulatory landscape and requirements for Asia, Preferably for EU and USA, too
  • An analytical and strategic approach to planning and problem solving
  • Excellent communication and interpersonal skills
  • Good command of spoken and written English and Chinese
  • Candidate with less experience can be considered as Regulatory Affairs Specialist

If you are interested in finding out more about this career opportunity, please email your resume to Christine Cheung, christinec@charterhouse.com.hk Tel: (852) 3151 1300 Web:www.charterhouse.com.hk


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