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Recruit Ref: L0598384141
Posting Date: 2025-05-28
Guerbet Asia Pacific Limited
Regulatory Affairs Specialist

Regulatory Affairs, Compliance and Administrative duties

Countries in the scope of responsibilities: ASEAN countries

 

Regulatory Affairs

  • Drive drug & medical device registrations and variations in accordance with relevant regulations and develop regulatory strategy to obtain the product approval within target timeframe.
  • Maintain Guerbet 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 
  • Maintain registration database locally
  • Support other regulatory topics in collaboration with cross-functional team, e.g. commercial, marketing and supply chain etc.

 

Compliance and Administrative Duties

  • 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. 
  • Maintain accurate information in product labelling by collaborating with  distributors and ensure compliance with local labelling requirements

 

Educations & Experiences

  • 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
  • Candidate with more experience will be considered as Senior Regulatory Affairs Specialist, whilst less experience will be considered as Regulatory Affairs Specialist

 

Skills & Qualifications

  • 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
  • Detail-oriented and cross-functional team player
  • Work precisely according to procedures, rules and regulations
  • Recognize recurring issues and analyse their causes in order to reach a solution

 

We offer a competitive compensation and benefits package to qualified applicants. This includes a 13th-month salary, clinical and dental coverage for staff and dependants , annual medical check-up, annual leave, birthday leave, and compensation leave.  Interested parties please submit your application by clicking the “Apply Now” button. 

 

For more information about Guerbet, please visit our website: https://www.guerbet.com/

 

All personal data collected will be treated with strict confidentiality and used solely for recruitment purposes.  If you are not contacted within 2 months of the closing date of the advertisement, please consider your application to be unsuccessful. 


Summary
Industry:
Manufacturing / Industrial 
Job Category / Function:
Job Position Level:
General 
Employment Term:
Full Time 
Min. Edu. Level Req:
Bachelor 
Minimum QF Level attained:
-- 
Total Working Exp:
-- 
Salary(HKD):
--
Location:
Kowloon City District / Hung Hom
Benefits:
  • Birthday Leave
  • Promotion
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Regulatory Affairs Specialist
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