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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Mongkok, Kowloon, Hong Kong
Job Description:
Job Summary
The Senior Regulatory Affairs Specialist (Hong Kong & Macao) is responsible for leading and executing regulatory activities to ensure compliance, timely product registrations, and lifecycle management of J&J Vision products in Hong Kong and Macao. This role provides regulatory expertise to support product registrations, renewals, promotional activities, and tendering, while ensuring alignment with local regulatory requirements, internal SOPs, and J&J quality standards.
Key Responsibilities
Regulatory Submissions & Lifecycle Management
- Lead and take ownership of regulatory dossier preparation for product registrations, renewals, and post‑approval changes in Hong Kong and Macao.
- Be accountable for achieving high‑quality, on‑time approvals for new registrations and changes, and ensuring 100% on‑time renewals prior to license expiry in both markets.
- Prepare, submit, and manage timely responses to regulatory authority questions and official correspondences.
- Maintain accurate regulatory databases, trackers, and archives for all Hong Kong and Macao regulatory documentation.
Regulatory Compliance & Intelligence
- Monitor, interpret, and assess changes in regulatory requirements, legislation, and guidance in Hong Kong and Macao relevant to J&J Vision products.
- Provide regulatory impact assessment, clear interpretations, and practical compliance recommendations to internal stakeholders.
- Ensure ongoing compliance of marketed products throughout their lifecycle in both markets.
Artwork, Labeling & Promotional Material Review
- Review and approve artwork, labeling, packaging, and IFUs to ensure consistency with approved registrations and local regulatory requirements for Hong Kong and Macao.
- Coordinate and support review and approval of promotional and educational materials in compliance with local regulations and internal review processes.
Business & Tendering Support
- Support regulatory inputs for Hong Kong and Macao tendering activities, including review of regulatory sections, compliance statements, and supporting documents.
- Act as the primary regulatory contact for product registration‑related inquiries from health authorities, customers, and internal teams in both markets.
Cross‑Functional Collaboration & Expertise
- Work closely with commercial, quality, supply chain, PD, and regional/global RA teams to support product launches and business continuity in Hong Kong and Macao.
- Serve as a regulatory subject matter expert for the HK & Macao markets.
- Contribute to continuous improvement initiatives, including SOP updates, process optimization, and regulatory best‑practice sharing.
Required Qualifications & Experience
- Bachelor’s degree or above in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related discipline.
- Solid experience in Regulatory Affairs for medical devices (and/or pharmaceuticals), with hands‑on responsibility for Hong Kong and/or Macao regulatory submissions.
- Good understanding of regulatory frameworks and submission processes applicable to Hong Kong and Macao.
- Proven ability to manage multiple regulatory projects with competing priorities.
- Strong written and spoken English; Cantonese / Chinese proficiency preferred for local communications & material review.
Preferred Skills & Competencies
- Regulatory Affairs Management & Regulatory Compliance
- Product Licensing & Lifecycle Management (HK & Macao)
- Regulatory Environment Assessment & Risk Evaluation
- Analytical Reasoning & Problem Solving
- Business & Regulatory Writing
- Strong Communication & Stakeholder Management
- Attention to Detail & Data Integrity
- Confidentiality & Ethical Business Conduct
- Teamwork & Cross‑Functional Collaboration
**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