Purpose of the Role:
The Regulatory Affairs Associate will provide comprehensive administrative and technical support to the Regulatory Affairs (RA) team in ensuring timely preparation, submission, and maintenance of product registrations and post-approval activities. This role is crucial in assisting with regulatory documentation, coordination with manufacturers, and ensuring compliance with local regulatory requirements.
Key Responsibilities:
Dossier Preparation & Submission
- Support the preparation, compilation, and submission of product registration dossiers to the Hong Kong Department of Health.
- Coordinate with internal teams and external partners to collect technical and administrative documents required for submission.
- Assist in reviewing and organizing quality, clinical, and administrative documents for compliance and accuracy.
Regulatory Documentation & Recordkeeping
- Maintain regulatory databases, submission trackers, and archives to ensure all records are accurate and up-to-date.
- Prepare standard templates, forms, and documents for local submissions.
- Ensure all correspondence, approvals, and regulatory commitments are properly filed and retrievable.
Product Lifecycle Management
- Support variations, renewals, labeling updates, and other post-approval changes.
- Monitor submission timelines and follow up with regulatory authorities and partners as required.
- Track and assist in responding to deficiency letters or information requests from the Department of Health.
Cross-Functional Coordination
- Liaise with global manufacturers, distributors, and local agents to ensure timely provision of data and documents.
- Collaborate closely with QA, Supply Chain, and Marketing teams to ensure product compliance and smooth market operations.
Compliance & Regulatory Intelligence
- Assist in monitoring local regulatory developments and updates from the Department of Health.
- Support the RA team in implementing changes to ensure ongoing compliance with updated guidelines and policies.
Qualifications & Experience:
- Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or related discipline.
- 1–3 years of experience in Regulatory Affairs within the pharmaceutical or healthcare industry.
- Strong understanding of the Hong Kong regulatory framework and documentation requirements.
- Experience with biosimilar submissions will be considered an added advantage.
- Excellent organizational, communication, and coordination skills.
- Attention to detail with the ability to manage multiple priorities in a deadline-driven environment.
- Proficiency in English; Cantonese proficiency preferred, Mandarin is an advantage.
Key Competencies:
- Strong documentation and administrative skills.
- Proactive, detail-oriented, and reliable team player.
- Good problem-solving and time management abilities.
- Ability to communicate effectively with internal and external stakeholders