·Act as a key interface between the New Product Development / innovation, manufacturing and marketing processes, providing key technical, scientific and regulatory input for product development and compliance ensuring timely product introduction to the market.
· Development and maintenance of product dossiers for regulatory affairs (i.e. tables of evidence, product specifications, CFDA submissions, etc.) and other departments and authorities as required.
·Working cross functionally, providing technical and regulatory advice across internal teams, including Customer Service, Quality Assurance, NPD, Operations, Digital and Marketing teams.
·Ensure regulatory compliance of therapeutic and non-therapeutic products by conducting regulatory reviews of product formulations for compliance against various domestic (CFDA) and international regulations, relevant codes of practice and market requirements
·Management & drafting of accurate product information. Approval of product labelling for
regulatory and technical compliance including the Chinese label of conventional food and
·Management of advertising reviews and approvals including, but not limited to promotional material for regulatory and technical compliance.
·Contribute to the development, implementation and maintenance of regulatory standard operating procedures, work instructions and data management to ensure due diligence and sponsor obligations are maintained at all times.
·Managing and resolving requests for further information for internal stake holders and
any government agency or external service provider as required and within a timely
manner consistent with Swisse quality and performance standards.
·Act as a key point of contact for the CFDA in conjunction with Biostime representation. Provide input into government consultations affecting the business.
·Manage product related complaints issued by regulatory bodies within a timely manner
consistent with Swisse quality and performance standards.
·Liaise with the Chinese industry bodies as required to support the business position and product range.
· Keep up to date with domestic and international regulatory considerations and changes.
· Manage different projects as required by the business in conjunction with multiple other
stakeholders both internal and external as required.
· Carry out the regulation affairs of importation food. Provide and clarify the regulatory
technical document to CIQ, such as the product formula, the Chinese label and other
· Complete health food product registration and notification including the preparation and
submission of the dossier and the related supplementation documents.
· Follow up CFDA panel review opinions.
· Resolve complaints and troubleshoot for the legal, customer service and quality departments.
·Qualifications in complementary medicine, health and/or life sciences.
· Minimum of 3+ years experience in technical and regulatory affairs.
· A sound understanding of therapeutic, technical and regulatory requirements for complementary medicines and foods/food supplements is essential.
· Understanding of technical, regulatory and legal issues relating to product listing, registration andmarketing.
· International, especially CFDA regulatory experience is considered an advantage.
· Established relationships with CFDA and other Chinese governing agency KOL’s and section leaders will be considered an advantage.