- Location
- Chai Wan, Hong Kong
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Manager
- Closing date
- Today
- Source
- Vincere
Description
Regulatory Affairs Assistant Manager / Manager – Getz Healthcare
Position Overview
The Regulatory Affairs Assistant Manager / Manager will support regulatory operations to ensure compliance with healthcare regulations and enable timely product registrations. This role involves preparing submissions, coordinating with internal teams, and liaising with health authorities to maintain approvals for pharmaceutical and medical device products.
Key Responsibilities
- Regulatory Documentation
- Prepare, review, and submit regulatory dossiers, variations, renewals, and post‑approval changes.
- Maintain accurate records of submissions and approvals.
- Health Authority Liaison
- Support communication with local and regional regulatory agencies.
- Assist in responding to queries and coordinating regulatory meetings.
- Compliance Support
- Review labeling, promotional materials, and packaging for compliance.
- Monitor regulatory updates and share relevant changes with internal stakeholders.
- Cross‑Functional Collaboration
- Work closely with QA, Medical Affairs, and Commercial teams to ensure regulatory alignment.
- Provide guidance on regulatory requirements during product development and launch.
- Lifecycle Management
- Support maintenance of product registrations and renewals.
- Assist in preparing periodic safety reports and post‑marketing commitments.
Qualifications
- Bachelor’s degree in Pharmacy, Life Sciences, or related field.
- 3–6 years of regulatory affairs experience in pharmaceuticals or medical devices.
- Familiarity with Hong Kong and Asia‑Pacific regulatory frameworks.
- Strong organizational skills with attention to detail.
- Good communication and interpersonal skills.
Skills
Compliance
