Regulatory Affairs Specialist

Global leader in medical imaging with products and solutions for diagnostic and interventional radiology.

Your new role

  • Drive drug & medical device registrations and variations in accordance with relevant regulations and develop strategies to obtain the product approval within target timeframe.

  • Maintain products’ licenses in responsible countries

  • Keep abreast of regulatory procedures and product changes to ensure registration dossiers are maintained in compliance with local and corporate instructions.

  • Effectively communicate and collaborate with local RAs and HQ RA team in France and US in order to develop Regulatory Strategies

  • Provide local regulation intelligence to internal stakeholders

  • Ensure company’s products comply with the regulations

  • Plan and coordinate packaging changes with related departments
  • Ensure validation of promotional materials in compliance with local regulations and corporate policy.

What you'll need to succeed

  • Bachelor’s degree in health-related science, life science; Pharmacist or related academic background is preferred

  • 3–4 years of relevant experience in pharmaceutical registration and experience in medical device registration in ASEAN countries and/or Hong Kong is preferred

  • Excellent verbal and written communication skills in English and Cantonese
  • Proficient in MS Office, including Word, Excel and PowerPoint
  • Previous experience in a multinational environment
  • Effective communication and interpersonal skills


What you need to do now

If you're interested in this role, please send your updated CV to rooney.wu@hays.com.hk


Summary

Job Type
Permanent
Industry
Healthcare & Medical
Location
HongKong
Specialism
Life Sciences
Ref:
1270610

Talk to a consultant

Talk to Rooney Wu, the specialist consultant managing this position, located in Hong Kong
6604-06,66/F, ICC, 1 Austin Road West, West Kowloon

Telephone: +85266232032

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