Regulatory Affairs Specialist

Job Description

• Will lead and coordinate the Regulatory Affairs activities in China, ensuring compliance with current legislation and guidelines in the target marketing regions. 
• Support Innovation and Development department, advising on regulatory requirements during product development processes. 
• Ensure that company policies and procedures in the regulatory affairs area are understood and implemented. 
• Prepare technical documents and manage database systems to allow traceability of technical and regulatory information on materials and products. 
• Ensure that regulatory trends and changes are identified, understood, and promptly communicated to key stakeholders. 。
• Present documentation to regulatory agencies and carry out any subsequent negotiations necessary to obtain or maintain authorization for products or technologies. 
• You will be an excellent communicator in demonstrating strong project management, writing, coordination and execution of regulatory items, with an emphasis on technical and scientific regulatory activities. 
• Preparing response to regulatory Authorities and queries within assigned timelines.
• Propose testing and analyze scientific data required to assess and ensure compliance.
• Acting as a liaison between the organization and local authorities to submit required forms and paperwork. 
• Ensure business continuity by influencing policymaking by doing advocacy. 
• Ensure that the position is appropriately resourced and equipped to carry out the required range of activities. 
• Accountable for ensuring best-in-class service to both internal and external customers/stakeholders.
• Plan and develop personal expertise through training in the identified areas of focus. 
• Maintain a safe and incident-free working environment. 

Qualifications

• Bachelor, Master’s degree, or PhD in chemistry, food science and technology, or any relevant discipline
• In-depth knowledge of food packaging material regulations in China and knowledge of other relevant APAC legislation on food contact materials 
• Experienced and knowledgeable of the Chemical regulation preferable with toxicology experience, in manufacturing and regulatory affairs, with at least 3 years’ experience.
• Excellent written and verbal communication skills with the ability to listen, articulate, advocate and influence business strategy and decisions.