Regulatory Affairs Specialist - Manager (FSP)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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