Regulatory Affairs QC Associate Manager

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Job Description

1. Drive RA compliance excellence to meet internal process requirements and external legislation.
2. Drive cross function efforts to achieve Labelling E2E compliance excellence
3. Represent RA and provide LOC RA input to corresponding quality functions and project teams
4. Provide mentoring and coaching to junior staff members
5. Build RA quality culture

Principal Accountabilities:
1. Regulatory compliance oversight and support for Quality Management System building, including development of RA compliance plan and quality metric, and contribution to quality system of Business quality, R&D quality, Site quality and others
2. Drive internal regulatory process development to reflect internal process and external legislation change, including labelling E2E process optimization, to reflect regulatory environment change, business model changes, and to mitigate identified gaps.
3. Driving training compliance, including completion rate review and building RA new hire training system
4. Driving system compliance and data accuracy, including new system launch readiness.
5. Leading China RA record Management, to ensure timely record archiving and retention, to support product LCM
6. Driving RA risk assessment development and periodically review, to identify potential risk and develop mitigation plan, therefore to ensure business continuity
7. Management of audit and CAPA
8. Credo based behavior with regulatory compliance excellence

Dimensions of Job:
(Please provide quantitative indicators on which the job has impact – e.g., earnings, revenue, budget, staffing, etc. Include indicator that best represents the main purpose of Job.)
1. Regulatory compliance oversight and support for Quality Management System building
2. Labelling E2E labelling process optimization and operation excellence to support new product launch acceleration and marketed products compliance
3. Liaise with quality functions: BQ/ R&D QM/ GRA QM etc
4. Regulatory process development & resource planning

Key Performance Measures: 
(Please list the key performance measures of this job)
1. RA quality metrics are well defined and implemented 
2. Labelling process high efficiency and AW high quality
3. No critical finding 
4. Strong cross-team connection and leadership

1. A bachelor degree major in chemistry, pharmaceutics, biology or a related life-science discipline. A master degree or above is preferable
2. At least 5-8 years of working experience. At least 2 years’ experience in managerial role is preferred.
3. Strong oral & written communication skill; good leadership capability and ability to work under pressure. Demonstrated ability to effectively manage.
4. In-depth knowledge of regulations and guidelines, esp. labelling
5. Proficiency in verbal and written English; good computer skill, good presentation skill.

Primary Location
J&J (China) Investments Ltd A- Beijing Branch (7075)
Job Function
Regulatory Affairs
Requisition ID