Market Entry & Compliance
• Lead regulatory approval processes for China market
• Develop and implement compliance strategies for product ingredients, labeling, claims, and packaging in alignment with local laws, regulations, and standards
• Coordinate cross-functional teams (R&D,FSQ,Marketing,Legal) to ensure compliance across product lifecycle
• Provides regulatory input and guidance to NPD and VE projects
Stakeholder Engagement
• Serve as primary liaison with regulatory authorities (e.g.SAMR, NHC, FDA) and industry associations and represent the company in policy making and consultations.
• Build technical influencing strategies and consistently advocate for the company
Risk Monitoring & Management
• Real-time monitor the regulatory landscape, including legislation and enforcement, conduct competitor analysis and share insights, and provide predictive analytics
• Track regulatory changes and assess business impact, address regulatory concerns with innovative solutions
• Issue and crisis management
• Lead escalation process and coordinate the cross-functional product risk review committee
• Educate, train & advise company professionals to ensure compliance with regulatory requirements
Function Management
• Lead China RA team by coaching team members, providing professional guidance, and sharing best practices
• Drive adoption of regulatory technology (RegTech) systems and tools
• Develop and maintain departmental working guidelines and standard processes
• Establish and maintain the regulatory master files
Job Requirements
• Bachelor’s degree or above, majoring in food science, food nutrition, public health, pharmacology, chemistry, or other related subjects.
• At least ten years’ experience in regulatory affairs and three years’ experience in food industry
• Proven analytical skills in regulatory risk management
• Good written and verbal communication in Chinese and English
• Strong interpersonal skills and ability to foster strong working relationships with key stakeholders (internally and externally)
• Strong technical knowledge of China food regulatory requirements and is able to critically analyze scientific data
• Ability to effectively manage multiple projects in a fast-pace, results oriented environment
• Self-motivated, good team player, can work under pressure
