Senior Regulatory Affairs Associate

Our client is a U.S listed medical company focusing on woman's health products. Currently looking for a Senior Regulatory Affairs Associate to support their fast-growing team.

Key Responsibilities:

• Provide regulatory support on data collection, database maintenance, record tracking and report dissemination
• Support regulatory submission, review and approve required documents, make regulatory filing determinations for product and process changes
• Maintain high standard of regulatory compliance and deliver projects on a timely basis
• Work closely with the team and report to the Senior Manager; Liaise and collaborate with various stakeholders in relation to all regulatory issues
• Maintain current information and awareness of regulatory intelligence, including regulatory agency guidance and procedures, and provides updates to the teams
• May have opportunities to cover Quality Assurance (QA)/ Pharmacovigilance (PV)

Key Requirements:

• Bachelor’s degree in Medical Science or relevant discipline is preferred
• 3+ years of hands-on work experience in regulatory, preferably in pharmaceutical/ medical device company
• Passion and experience in women health is highly 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