Principal Responsibility

• Ensure all existing and new drug products comply with the updated China authority requirement and registration approval timely.
• Maintain current marketed drug product license & approval and enhance drug products variation application registration and approval in terms of business needs
• Prepare and submit registration dossier and deficiency response timely in terms of company internal data and comply with China regulatory requirement and guideline.
• Lead regulatory long term and short term strategy development in line with business LRP and the consensus with local and divisional team across different functions within Abbott Nutrition.
• Build and improve network and engagement with internal and external stakeholders especially NMPA, CDE.
• Proactively anticipate and influence government policy/regulations to effectively protect/advance company’s interests
• Provide drug regulatory knowledge training and updates to internal different functional

teams.

Education and working experience

• A Bachelor’s degree in pharmacy, nutrition, chemistry, pharmacology or related life sciences is required
• Minimum of 5 years experience preferred in pharmaceutical regulatory affairs especially maintaining and enhancing current marketed drug product approval.
• Having experience interfacing with government regulatory agencies and proven skill at developing and implementing successful China regulatory strategies.
• Expect relevant experience of a broad range regulatory work in the ethical pharmaceutical industry

Other Special requirement:

• Experience working in a complex and matrix environment is required.
• Up to date knowledge of drug legislation and regulations
• People management skill and experience
• Learning agility
• Fluent spoken and written Enghlish skill