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 Consultant (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

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere.

Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

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