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Regulatory Affairs Specialist - Manager (FSP)
Primary Location: Hong Kong, Remote Job ID R0000045897 Category Regulatory / Consulting Date Posted 09/12/2026Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
The Regulatory Affairs Senior Specialist or Manager is responsible for supporting regulatory operations, submission execution, and lifecycle management activities for client's portfolio in Hong Kong and Macau.
This role works closely with internal stakeholders, external partners, and Heath Authorities to ensure timely submissions, regulatory compliances, and effective execution of regulatory activities.
This FSP role will need to be able to work at client's office (Location: Hong Kong)
Key Accountabilities:
- Prepare, submit, and track regulatory applications, including clinical trial applications, import permits, marketing applications, variations, and renewals.
- Support product registrations and post-approval lifecycle management activities.
- Coordinate regulatory submission activities with internal teams, external partners, and Health Authorities.
- Maintain regulatory documentation, submission records, and regulatory archives in accordance with company policies and local requirements.
- Support regulatory inspections, audits, and Health Authority requests as needed.
- Develop and maintain local regulatory procedures and working practices.
- Monitor local regulatory requirements and communicate relevant regulatory updates to stakeholders.
- Collaborate cross-functionally to support regulatory and business objectives.
Knowledge and Experience:
- With a minimum of 3-5-years regulatory affairs experience > Upon experience level, suitable title (Senior Specialist; equivalent to Senior Associate or up to Manager equivalent title) will be offered.
- Experience and knowledge in preparation of INDs and NDA/BLAs
- Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle
- Command of written and oral English, Cantonese, and Mandarin
- Travel: As required by the company.
Education:
- Minimum of a Bachelor’s Degree in a relevant study field
- Advanced Degree Preferred
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