Regulatory Affairs Associate Manager_Hema
Beijing, China | Johnson & Johnson
Job Description:75 people have viewed this job
Summary of job responsibilities:
1.Support regulatory submission activities for assigned projects
2.Execute regulatory strategy plans to deliver CTA & NDA/BLA filings and provide RA support to China compound teams for assigned projects
3.Execute regulatory strategy plans to support successful LCM of responsible marketed products
4.Support timely Regulatory filings and response to HA queries
5.Establish a relationship with HA and collaborate with key stakeholders in the local, regional and global organization
Dimensions of Job:
1.Regulatory support for assigned R&D projects including registration pathway and acceleration strategy, as well as input to R&D functions and/or China compound teams
2.Regulatory support for responsible marketed products, as well as input to BU and product teams
3.Liaise with Regulatory agency
4.Regulatory process development & resource planning
Principal Accountabilities of Job:
1.Collaborate with global, regional and local product teams to develop and implement registration plan and regulatory strategy.
2.Execute regulatory activities & review critical submissions for assigned projects
3.Support timely Regulatory submission and team response efforts to HA request.
4.Lead cross-functional preparation for CDE consultation meetings.
5.Interact with HA review divisions.
6.Actively involved in the review and revision of regulations, guidelines.
7.Develop internal regulatory process for effective operation.
8.Credo based behavior with regulatory compliance excellence.
Key Performance Measures:
1.Regulatory strategy development and execution for assigned projects
2.Timely delivery of regulatory submissions with high quality
3.Strong HA connection
4.Others:Strategic thinking, Cross-functional collaboration
- Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred
- Around 4-5 years Regulatory experience
- New product registration experience
- Strong oral & written communication skill; ability to work under pressure.
- In-depth knowledge of regulatory environment, regulations and guidelines.
- Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization.
- Proficiency in verbal and written English; good computer skill, good presentation skill.
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