Summary
Manages a team of individual contributors and/or supervisors and is accountable for conducting effective performance management. Benchmarks Regulatory Affairs strategies, assessments, and policies accounting for new and changing government regulations. Directs resources internally and externally to ensure compliance with regulatory agency regulations and interpretations and advises management on trends in the global regulatory environment.
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
CN002 Beijing Jianguo RoadJob Description:
Job Description
OVERALL RESPONSIBILITIES:
Work closely with APAC regional Special Project RA lead, global PMOs & Serve as the overall Country Special Project RA lead in China to execute the MD RA Special Project initiatives.
Serve as a key RA lead by demonstrating strong collaboration skills, partnering with key stakeholders and working with leaders at all levels in the organization
Adherence to J&J CREDO and industry code of conduct, ethics and good regulatory practices, align team members with J&J CREDO. Ensure 100% compliance with local legislation, global regulatory policies, J&J CREDO.
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, Supply 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
- 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
