- Location
- HK001 Mongkok, Hong Kong
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Senior
- Closing date
- Today
- Source
- Workday
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.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Mongkok, Kowloon, Hong KongJob Description:
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
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork
