任职资格:
MINIMUM JOB REQUIREMENTS
BS/BA or in scientific field required or relevant experience or master degree
Minimum 3 years of experience for master and 5 years of experience for bachelor
Good verbal, and interpersonal communication skills and strong attention to detail in English and/or Japanese
Excellent understanding of pharmaceutical laws and relevant regulations in China
Good understanding of clinical trials and clinical strategy
Good understanding of global regulations such as ICH, and relevant regulations in China as needed
Proficient in the use of common Microsoft software programs and document management systems
PREFERRED SKILLS AND EXPERIENCE
Advanced degree in life science or other relevant discipline
Good project management and organizational skills; ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment
Ability to work on multiple projects
Self-starter and problem solver
Meet established timelines
Technical writing preferred
Ability to work well in a team environment
Excellent communication skill in English
主要岗位职责:
PURPOSE AND SCOPE OF POSITION
Regulatory Expert will be responsible for leading and coordinating communication with regulatory authorities and engaging in development project from regulatory affairs perspective through collaborating with project members. Regulatory Expert will also provide regulatory intelligence for development project.
DUTIES AND RESPONSIBILITIES
Organize China NDA submission including CTD preparation by coordinating project team
Lead, establish and maintain communication with CDE and other authorities for consultations, NDAs and Re-Evaluation
Support global submissions, such as INDs, NDAs including organizing submission and review process, preparing regulatory sections, reviewing for completeness, accuracy and appropriateness of documentation, and compiling dossier
Coordinate communication with CROs and consultants for appropriate regulatory decisions
Interpret and advice regarding regulations, key issues, risks and any other critical topics to interdisciplinary teams and other groups within and outside the organization in order to maximize the business benefit and maintain regulatory compliance
Offer leadership on project teams with regard to regulatory issues
Support and assist with development of regulatory strategy for China approvals