China Special Projects RA Lead
J&J Family of Companies
POSITION DUTIES & RESPONSIBILITIES:
+ Lead China Special Project RA team to develop regulatory strategies for all the special projects by gaining alignments with the internal partners across Johnson & Johnson (including global PMOs, local RA, Suply Chain, Marketing & Quality etc.) to ensure that the stakeholders' voices are evaluated within the strategies
+ Provide prioritization, capacity management, and efficiency gain options for Special Project program in China
+ Work collaboratively with country or local Franchise RA leaders to lead executions of all Special Projects
+ Be accountable for completing Special Project impact assessments on time
+ Be responsible for completing all the RA actions accurately and on time delivery per project plan
+ Lead China Special Project RA team to set project plan with the detailed tasks and timeline for each Special project to avoid any registration misses
+ Ensure timely MDRiM updates for each RA action, SEP dates, license update and code linkage to country license per process SOPs
+ Be part of APAC Special Project RA leadership team and represent China to work with the team to create and share the best practices on the Special project executions
+ Be responsible to achieve and maintains the appropriate metrics for China Special Project program per 2025 G&Os
+ Recruit and hire Special Projects RA resources as needed
+ Ability to manage multiple priorities is required.
+ Work across the APAC region to create and share the best practices on the execution of the strategy for executing multiple Special projects
+ Ensure applicable company compliance with all relevant country and regional requirements, company regulations, policies and procedures.
+ Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
+ Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
+ Effective lead and coaching team members, motivating group to work more efficiency, manage and develop people and talent, to build collaborative, high performance team
**Qualifications**
Qualifications
+ A minimum of a Bachelor’s Degree of Engineering or Science with 7+ years of regulated industry experience, inclusive of regulatory affairs, (OR an advanced degree with 5+ years) is required.
+ Medical Device industry experience is preferred.
+ Previous experience managing, or leading projects is required
+ Excellent written and verbal communications skills in English are required
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