Regulatory Affairs Consultant
3 days ago
We are seeking a highly experienced Regulatory Affairs Consultant to support the implementation of regulatory strategies in Saudi Arabia and the GCC region. This role is integral to ensuring compliance with the Saudi Food and Drug Authority (SFDA) and Gulf Health Council (GHC) regulatory requirements, with a focus on pharmaceutical products, vaccines, and biological products.
As a consultant, you will play a pivotal role in engaging with stakeholders and ensuring that all regulatory submissions are compliant with local and regional guidelines.
Key Responsibilities:
- Lead regulatory interactions with SFDA and GHC, ensuring effective communication on regulatory issues.
- Review product dossiers and identify deficiencies, providing recommendations to streamline the registration process.
- Monitor and interpret the latest regulatory requirements in Saudi Arabia and the GCC.
- Engage with government authorities to support the registration of new products and contribute to other strategic projects.
Preferred Qualifications and Experience:
- Minimum of 5 years of experience in regulatory affairs, ideally with expertise in vaccines or biological products.
- In-depth knowledge of regulatory requirements in Saudi Arabia and the GCC region.
- Proficiency in both Arabic and English, with exceptional communication and public relations skills.
- Previous experience working as a regulatory liaison for national or regional markets is highly desirable.
Why Join Us:
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases. Our mission is to supply vaccines to eliminate human diseases. We are actively seeking a Regulatory Affairs Consultant who is experienced in regulatory affairs to facilitate regulatory work in Saudi Arabia and the GCC region. If you are passionate about regulatory affairs and want to make an impact in a multinational environment, we encourage you to apply.
Seniority levelMid-Senior level
Employment typePart-time
Job functionConsulting, Health Care Provider, and Science
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