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/

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