(Assistant) Regulatory Affairs Manager 

Our client is an established and fast-growing MNC pharmaceutical organization with a strong global presence and integrated capabilities across development, manufacturing, and commercialization of high-quality medicines. They are currently expanding their footprint in Hong Kong and are seeking a Regulatory Affairs professional to support their growing pharmaceutical portfolio.

This is an excellent opportunity to join a dynamic and collaborative team environment, playing a key role in bringing affordable medicines to market and supporting public healthcare access in Hong Kong.

Key Responsibilities

Regulatory Submissions, Tender Management & Compliance

• Prepare, review, and submit pharmaceutical registration dossiers to the Hong Kong Department of Health (DH)
• Ensure all submissions comply with local regulatory requirements and guidelines
• Monitor regulatory changes and assess their impact on product registrations
• Support and manage Hospital Authority (HA) tender submissions, including documentation preparation and compliance checks
• Coordinate post-submission follow-ups and maintain communication with relevant stakeholders

Regulatory Strategy & Lifecycle Management

• Conduct gap analyses for new and existing products to ensure readiness for registration and compliance
• Manage post-approval activities including variations, renewals, and labelling updates
• Maintain regulatory documentation and ensure ongoing compliance

Cross-functional Collaboration

• Liaise with internal teams (e.g., Quality Assurance, Pharmacovigilance, Commercial) to align on regulatory strategies
• Coordinate with external partners, distributors, and regulatory authorities to facilitate timely approvals

Key Requirements

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or related discipline
• Minimum 2 years of hands-on experience in drug registration and dossier submissions in Hong Kong (CTD/eCTD)
• Experience supporting Hospital Authority (HA) tendering processes in Hong Kong
• Strong knowledge of local regulatory requirements; exposure to international frameworks (e.g., FDA, EMA, PMDA) is a plus
• Excellent analytical and problem-solving skills with strong attention to detail
• Effective communication skills in English and Cantonese; Mandarin is an advantage
• Ability to manage multiple priorities in a fast-paced environment
• Prior experience with local pharmaceutical companies or distributors is preferred
• Exposure to Pharmacovigilance is an advantage but not essential

Why Join?

• Be part of a growing pharmaceutical platform with strong global backing
• Opportunity to work across the full regulatory lifecycle, including tendering for public healthcare access
• Regional exposure and collaboration with cross-functional teams
• Dynamic, growth-oriented environment with strong career development potential

What’s Next?

If you are looking to grow your career in Regulatory Affairs within the Hong Kong pharmaceutical industry, we would love to hear from you.

Apply now or send your CV to tiffany.wong@linksinternational.com for a confidential discussion about this opportunity and the broader healthcare landscape in Hong Kong.