Senior Regulatory Affairs Specialist - Vision Care

We are searching for the best talent for Senior Regulatory Affairs Specialist, Hong Kong & Macau.

Purpose:

The Senior Regulatory Affairs Specialist is responsible for leading and executing regulatory affairs activities for the Johnson & Johnson Vision portfolio across Hong Kong and Macau. This role ensures regulatory compliance, timely product registrations, and effective lifecycle management while serving as a trusted regulatory partner to support business growth, product launches, and market continuity.

The position plays a critical role in navigating the local regulatory landscape, providing strategic regulatory guidance, and collaborating with cross-functional stakeholders to ensure products are maintained and marketed in compliance with applicable regulations and company quality standards.

You will be responsible for:

• Leading the preparation, submission, and maintenance of regulatory dossiers for new product registrations, renewals, and post-approval changes across Hong Kong and Macau
• Driving timely regulatory approvals and ensuring uninterrupted product lifecycle management through proactive planning and execution of renewal and variation activities
• Managing regulatory authority interactions, including preparing responses to agency queries, coordinating official correspondence, and ensuring timely resolution of regulatory issues
• Monitoring and interpreting evolving regulatory requirements, legislation, and guidance to assess business impact and provide actionable compliance recommendations
• Reviewing and approving product artwork, labelling, packaging, Instructions for Use (IFUs), and related materials to ensure compliance with approved registrations and local regulations
• Supporting promotional and educational material review processes to ensure adherence to local regulatory requirements and internal review standards
• Providing regulatory expertise and support for tender submissions, product launches, and commercial activities while serving as the primary regulatory contact for registration-related enquiries
• Collaborating with local, regional, and global stakeholders to drive continuous improvement initiatives, strengthen regulatory processes, and promote regulatory excellence across the organisation

Qualifications / Requirements:

• Bachelor’s degree or above in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related scientific discipline
• Proven Regulatory Affairs experience within the medical device, healthcare, pharmaceutical, or life sciences industry
• Hands-on experience managing product registrations, renewals, and lifecycle activities for Hong Kong and/or Macau markets
• Strong understanding of local regulatory frameworks, submission requirements, and compliance obligations applicable to healthcare products
• Demonstrated ability to manage multiple projects simultaneously while maintaining high standards of quality, accuracy, and timeliness
• Strong analytical thinking and problem-solving capabilities, with the ability to evaluate regulatory risks and recommend practical solutions
• Excellent written and verbal communication skills in English; Cantonese and Chinese language proficiency is highly preferred
• Strong stakeholder management skills with the ability to collaborate effectively across Quality, Commercial, Supply Chain, Regulatory, and Regional teams