Global Director Regulatory Affairs (Bilingual Chinese)
My client is a global biopharmaceutical company focusing on developing treatments for autoimmune, oncology and ophthalmic diseases with unmet needs. They are looking to add a fully remote Global Director of Regulatory Affairs who is fluent in both English and Chinese Mandarin.
The Regulatory Affairs Director will be responsible for:
- Representing regulatory affairs in project meetings and in the preparation of regulatory documents.
- Serving as the internal expert in international RA by providing guidance to management and project teams for international registration of new products/indications for the US, EU, and Australia.
- Organizing FDA communication meetings and providing interpretation of regulations and interactions with agencies (FDA, EU, etc).
The Regulatory Affairs Director should have the following qualifications:
- 10+ years of Regulatory/industry experience in biotech/pharmaceuticals.
- Bilingual in both English and Chinese Mandarin.
- 8+ years as the Global Regulatory Lead representative on project development teams.