Associate RA Director, Policy and Intelligence

职位描述


1. Adhere to J&J credo and industry code of conduct, ethics and good regulatory practices, comply with local legislations and global regulatory policies.
2. Regulatory Science Work
Lead China Regulatory Science team and collaborate with other group leaders to coordinate and facilitate shaping and improving the China regulatory environment with following activities:
1) (Accelerate Harmonization/Regulatory Convergence) By working with NMPA (National Medical Products Administration) and other key external stakeholders, actively engage in promotion of harmonization of China’s regulatory regime with the globally recognized standards, covering such as global regulation developing trends and initiatives from international organizations, e.g. IMDRF.
2) (Policy Shaping/commenting) Monitor the new regulation or regulation in drafting stage; lead the policy commenting process and present the J&J position papers or comments; lead impact analysis of new regulation for J&J and put forward strategic approaches to internal stakeholders in response to China’s regulatory changes.
 Proactively work on China Medical Device regulations, comparatively study the relevant overseas regulations (USA, EU, Japan, and other global regulations), provide comprehensive and reasonable proposals, share with internal/external stakeholders if appropriate;
3) (Industry engagement) Actively contribute to the activities of Medical Device industry associations, lead industry discussions on regulations & policies, and join the workshop/roundtable discussions with other related stakeholders, e.g. EUCCC, AdvaMed, CAMDI and APACMed, etc.
4) (Intelligence sharing) Update and share with internal stakeholders on China’s new regulatory requirements and processes, communicate China policy trends to regional and global policy team, establish relationship with regional and global RA team as the China policy contact.
3. Closely collaborate with and provide support to the rest of China RA team (including other sector RA team if needed) to facilitate cooperative projects and workshops for NMPA and its affiliated agencies.
4. Manage and develop people and talent, build a high-performance China Regulatory Science team.
5. Fulfil other tasks assigned by supervisor.


资历
At least bachelor degree on medical, pharmaceutical, biology or related regulatory, legal or medical management, master degree is preferred.
At least 12-15 years working experience and 5 years leadership experience in regulatory science or other related areas in healthcare industry.
Solid knowledge and experience in regulatory science, compliance and communication in healthcare industry.• Fluent in English, especially listening, oral and written.
Good communication and presentation skills.
Good leadership skills.
Good project management skills.


主要地点
中国-北京-北京-
组织
强生(上海)医疗器材有限公司
工作
Regulatory Affairs
Requisition ID
1905757701W