About the Company

We are a pioneering biopharmaceutical company that successfully launched the first approved MSC-based cell therapy in China. Our mission is to transform patient care through innovative regenerative medicine. As we expand globally, we are seeking a regulatory affairs professional to lead our efforts in obtaining approval for our breakthrough therapy in Hong Kong, leveraging 1+ mechanism and other strategic pathways.

Key Responsibilities

• Regulatory Strategy & Planning

  • Develop and execute regulatory strategies for Hong Kong market entry, aligning with corporate objectives and compliance requirements.
  • Leverage China’s approval status and 1+ mechanism to accelerate local registration and approval processes.

• Submission & Documentation

  • Prepare, review, and submit regulatory dossiers to the Department of Health (Hong Kong) and other relevant authorities.
  • Ensure timely responses to regulatory queries and manage post-submission follow-ups.

• Cross-functional Collaboration

  • Work closely with clinical, quality, and manufacturing teams to ensure regulatory compliance throughout the product lifecycle.
  • Liaise with external stakeholders, including regulatory agencies, consultants, and industry associations.

• Compliance & Risk Management

  • Monitor changes in Hong Kong regulatory frameworks for cell and gene therapies.
  • Maintain compliance with GMP, GCP, and other applicable standards.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or related field.
• 5+ years of regulatory experience in biopharmaceuticals, ideally with cell therapy or advanced therapy medicinal products (ATMPs).
• Proven track record in drug registration in Hong Kong or China; experience with 1+ mechanism is highly desirable.
• Strong understanding of ICH guidelines, local regulatory requirements, and global best practices.
• Excellent communication and stakeholder management skills.

Preferred Attributes

• Experience in CMC documentation for cell-based products.
• Ability to navigate complex regulatory environments and propose innovative solutions.
• Fluent in English and Chinese (Cantonese/Mandarin).

Why Join Us?

• Be part of a first-in-class therapy shaping the future of regenerative medicine.
• Opportunity to lead regulatory strategy for a high-impact product in a growing market.
• Competitive compensation and benefits package.