Regulatory Affairs, Assistant Manager (Pharma & Medical Device)

Our client is local conglomerate, looking for a RA talent for their pharmaceutical and medical device business.

Key Responsibilities

• Ensures that regulatory strategies meet current and future customer needs and are executed in compliance with current applicable regulations and standards
• Work closely with the team and report to the Senior Manager of RAQA
• Liaise and collaborate with internal and external stakeholders in relation to all regulatory issues
• Support regulatory submission, review and approve required documents, make regulatory filing determinations for product and process changes
• Maintain current information and awareness of regulatory intelligence, including regulatory agency guidance and procedures, and provides updates to the teams
• Monitor impact of new and impending regulatory changes and advises management on optimum methods to achieve compliance

Key Requirements

• 5+ years of hands-on work experience in regulatory, preferably in pharmaceutical/ medical device company
• Bachelor’s degree in Medical Science or relevant discipline is preferred
• Deep understanding and knowledge of HK regulatory affairs principles, practices and systems, especially in the area of pharmaceutical/ medical devices
• History of successful submission of regulatory filings, with acceptance or approval by regulatory agencies
• Ability to read, analyze, and interpret technical dossiers, general business periodicals, professional journals, technical procedures, and governmental regulations
• Excellent communication skills, including writing, verbal, interpersonal skills, and negotiating skills
• Good commands in spoken and written Cantonese and English