Associate Director, Regulatory Affairs, Tigermed, US Based
- To establish and maintain regulatory team in the United States；To perform project supervision activities timely and effectively to ensure the running of the responsible Regulatory Team goes smoothly.
- To participate or lead regulatory project related to US FDA filing.
- Be responsible for the management of operation on the responsible Regulatory Team, achieve the team business objectives.
- Be responsible for building and maintaining the good relationship with important RA-related business clients and various regulatory authorities esp. US FDA.
- Be responsible for the coordination and supervision of the registration project, to provide the regulatory guidance, support in RA team if necessary.
- Be responsible for supporting the company’s business development department in determining the business development strategies and participating important RA-related BD activities if necessary.
- Be responsible for working with HR Dept. for RA-related staffs training, keeping and developing RA talents.
- Be responsible for providing support to other functional departments on view of regulatory affairs.
- Academic / Major -Bachelor’s degree or above; Major in pharmaceutical, medical, biological, life science, English, Japanese and other related discipline.
- Professional Skills-have full knowledge of regulations in relevant countries or regions.
- Working Experience-Minimum 7+ years of R&D working experience or RA experience or R&D plus RA experience.
- Language ability-Fluent English and Chinese to effectively communicate with sponsor about the regulatory needs in the United States.
- Computer Literacy
- Well verse in MS Excel, Word and PowerPoint and general computer skills.