Assistant Regulatory Affairs Manager

Responsibilities:

• Handle all regulatory issues and dossier preparation of pharmaceutical registration.
• Maintain the pharmaceutical registrations through timely renewal of related certificates and life cycle management.
• Ensure that all new products are registered by the local regulations and company policy in a defined timeline.
• Liaise with external bodies in regulatory affairs issues such as Department of Health and Hospital Authority.
• Ensure the application is in line with local and international regulations.
• Implement regulatory strategies to achieve rapid and high-quality approvals.
• Coordinate product registration and variation activities for new and existing products with overseas manufacturers.
• Respond to queries related to QA and products.
• Manage Pharmacovigilance.
• Ensure product compliance and product quality, especially for tender business.
• Provide regulatory support in tender submission and corresponding inquiry.
• Handle all related regulatory affairs projects if needed.
• Direct Report to the Head of Division.

Requirements:

• Bachelor’s Degree in Science-related disciplines (e.g. Biology, Pharmacology) or equivalent.
• 6-8 years of Regulatory Affairs experience in the Pharmaceuticals or Healthcare industry.
• Supervision to regulatory teammates by providing strategic approach.
• Good command of both written and spoken English and Chinese.
• Well organized, self-motivated, good communication and interpersonal skills to work with teams.