Regulatory Affairs Manager — HK/Macau

Parexel International; Hong Kong; Hybrid; HKD 600,000 - 900,000; Full time

Benefits offered by this job

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Job summary

Parexel International in Hong Kong is seeking a Regulatory Affairs Senior Specialist/Manager to support operations, submissions, and lifecycle activities for the Hong Kong and Macau portfolio. You will collaborate with internal teams, external partners, and Health Authorities to ensure timely regulatory actions.

The role requires 3–5 years of regulatory experience, knowledge of INDs/NDA/BLA processes, and proficiency in GMP/GLP/GCP.

Qualifications

• 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.
• Coordinate submission activities with internal teams, external partners and Health Authorities.
• Maintain regulatory documentation and archives per company policies and local requirements.
• Support regulatory inspections and audits as needed.
• Develop and maintain local regulatory procedures and working practices.
• Monitor local regulatory requirements and communicate updates to stakeholders.
• Collaborate cross-functionally to support regulatory and business objectives.

Responsibilities

• Prepare, submit, and track regulatory applications.
• Coordinate with internal teams and Health Authorities.
• Maintain regulatory records and archives.
• Assist regulatory inspections and audits.

Job description

Parexel International in Hong Kong is seeking a Regulatory Affairs Senior Specialist/Manager to support operations, submissions, and lifecycle activities for the Hong Kong and Macau portfolio. You will collaborate with internal teams, external partners, and Health Authorities to ensure timely regulatory actions.

The role requires 3–5 years of regulatory experience, knowledge of INDs/NDA/BLA processes, and proficiency in GMP/GLP/GCP.