Regulatory Affairs Head - CAR-T Therapy
Global CAR-T technology product at pre-commercialisation
Solid cell therapy pipeline for China
About Our Client
Our client is Shanghai based CAR-T pioneer company with exceptional local talents and global technical transfer. They are running GMP Manufacturing and Lab in Shanghai and get practices from US partner.
- Act as primary company liaison with the CFDA and relevant government bodies
- Provide analysis, advice and guidance on China regulatory strategies.
- Provide expertise on regulatory standards and departmental policies
- Utilise resources consistent with the overall goals and objectives of the RA department.
- Maintain current expertise on developments in the assigned therapeutic area
- Lead a team of 10 RA Specialists across Beijing and Shanghai office locations
- Support all current and future portfolio
The Successful Applicant
- Advanced Degree from an accredited institution in life sciences, pharmacy, or chemistry with extensive drug development knowledge.
- Critical thinker with ability to self-direct workload, including reprioritizing and delivery under tight timelines.
- Ability to analyse and interpret scientific data and regulatory guidelines
- Strong interpersonal skills supporting the ability to influence without authority, develop effective professional relationships, work in a matrixed team environment, and demonstrate sound conflict management and negotiation skills along with the flexibility and willingness to adapt to a changing environment
- Excellent oral, written and presentation skills with the ability to provide key messages in a concise manner.
- Demonstrated understanding of the regulatory process and technical competence in core areas of drug development for biologics and/or cell therapy.
- Requires a robust and broad range of China regulatory exposure and knowledge, from both strategic and operational perspectives.
- (In-depth) knowledge in RA gained through direct regulatory liaison with China FDA
- CDE Technical Evaluation, CDE Review, CTP Approvals, NDA Submission, CFDA
What's on Offer
You will be offered competitive salary and bonus package along with the opportunity to develop within the team of professionals.