- Initiate, track and facilitate new product registrations in US and achieve on-time approvals;
- Monitor regulatory environment changes and provide impact analysis plus action plans to ensure compliance;
- Interact with local regulatory authorities, experts and industry groups to drive new guidelines and regulations towards harmonized international standards;
- Give regulation guidance to research, development, manufacture and clinical team to push forward the progress of the project.
- Communicate with FDA or other authority group as representative of company.
- Report to RA director in China and assistant to communicate with US team and support registration in China.
- Bachelor’s degree or above in Pharmaceutical related discipline;
- Minimum 8 years’ experience in biopharmaceutical industry and minimum 5 years’ experience in RA function;
- Sound insight of the regulatory requirement with good networking and relationship with FDA;
- Strong interpersonal skills include negotiation skills and significant experience in interacting with regulatory authorities;
- A team player with good communication and influencing skills; Ability to lead, coach, and motivate others.