Sr. RA Professional

Sr. Regulatory ProfessionalLabelling

TheSr. Regulatory ProfessionalLabellingis 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 highquality labeling deliverables for submissions approvals and postapproval 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 labellingCoE 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

• Bachelors degree in Life Sciences Pharmacy Regulatory Affairs or related field (or equivalent experience). Amasterdegree or above is preferable.

• 25 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 problemsolving skills; ability to interpret regulatory feedback and translate into clear labeling actions.

• Proven project coordination and timemanagement skills; ability to manage multiple labeling activities and deadlines.

• Ability to work crossfunctionally and influence without direct authority.

• Proficiency with MS Office (Word Excel PowerPoint); experience with labeling management tools is a plus.