Associate RA Director, Policy and Intelligence
Associate RA Director, Policy and Intelligence
Posted on :
23-08-2025
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1 Vacancy
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Job Description
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.
to J&J credo and industry code of conduct ethics and good regulatory practices comply with local legislations and global regulatory policies.
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 Chinas 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 Chinas 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 Chinas 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.
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.
and develop people and talent build a high-performance China Regulatory Science team.
other tasks assigned by supervisor.
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.
to J&J credo and industry code of conduct ethics and good regulatory practices comply with local legislations and global regulatory policies.
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 Chinas 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 Chinas 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 Chinas 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.
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.
and develop people and talent build a high-performance China Regulatory Science team.
other tasks assigned by supervisor.
Required Experience:
Director
Employment Type
Full Time
Department / Functional Area
Key Skills
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