About the Role
The RA manager role will support the implementation of Hongkong's regulatory strategies and affairs for all products, assuring it is aligned with Hongkong’ requirements from a local perspective.
Job Responsibilities
- Communicate with Dept of Health to discuss regulatory issues and formulate local registration strategy.
- Screen deficiencies, review and submit relevant dossier to Dept of Health and follow up registration progress and status timely.
- License maintenance and post approval supplement, such as change control, pharmacovigilance support.
- Collecting relevant regulations and products information of other companies.
- Technical support to the sales department when requested
Preferred Qualifications
- Experienced on regulatory affairs，general experience on quality, GMP and clinical studies.
- Knowledge in regulations and WDL of Hongkong is essential.
- Language skills in excellent English and Cantonese, and Mandarin is essential.
- Preferred at least 5 years of work experience on pharmaceutical products, especially on vaccines or biological products.
- Previous experience as a national and/or regional regulatory liaison for a product in different stages of its life cycle is highly desirable.
- The position will require rich experience in regulatory affairs, strong communication skills and public relation skills, strong Hongkong’s background.
Job Type: Full-time
Language:
- English (Required)