Sr. RA Professional

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.