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 jnj.com.
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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory Product Submissions and RegistrationJob Category:
ProfessionalAll Job Posting Locations:
Beijing, ChinaJob Description:
Sr. Regulatory Professional – Labelling
The Sr. Regulatory Professional – Labelling is responsible for managing the creation, review, quality-control and maintenance of product labeling and associated artwork throughout the product lifecycle. This role coordinates cross-functionally to ensure timely, compliant, and high‑quality labeling deliverables for submissions, approvals, and post‑approval changes.
Key responsibilities
Product Insert, Package Label and Artwork QC review and documentation.
Labeling E2E activity tracking system maintenance.
Maintain labelling compliance following company policies and procedures.
Implement local labelling E2E process to comply with local regulations and global standards.
Collaborate with cross functions including XJP CQ, R&D QM, AP, global labelling CoE, and local/global cross-functions to ensure labeling process implementation and compliance.
Participate in labeling strategy and kickoff activities for new product/indication; support China Regulatory Labeling (RL) to develop, drive and maintain the labeling activity plan.
Prepare and maintain draft China labeling document based on global reference documents in collaboration with RL and cross-functional teams. Support RL to coordinate cross-functional review, QC review and sign-off following SOP and WI.
Draft Local Labelling Deviation Form, manage LLD tracking and handovers.
Support RL for health authority (HA) interactions: responses to HA labeling comments, implement agreed changes, and update labeling files accordingly.
- Contribute to continuous improvement of labeling processes, templates, checklists and training materials.
Perform related duties as assigned by supervisor.
Requirement
Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field (or equivalent experience). A master degree or above is preferable.
2–5 years’ experience in pharm (experiences in regulatory is preferred).
Excellent written and verbal communication skills in English; Strong attention to detail and accuracy in text and formatting.
Analytical mindset and problem‑solving skills; ability to interpret regulatory feedback and translate into clear labeling actions.
Proven project coordination and time‑management skills; ability to manage multiple labeling activities and deadlines.
Ability to work cross‑functionally and influence without direct authority.
Proficiency with MS Office (Word, Excel, PowerPoint); experience with labeling management tools is a plus.
Required Skills:
Preferred Skills:
Coaching, Communication, Competitive Landscape Analysis, Compliance Management, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Product Packaging Design, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Researching, Safety-Oriented, Sustainability, Sustainable Packaging