Regulatory Affairs Manager, China
Lesaffre · Shanghai
Company Description
As a global key player in yeasts and fermentation, Lesaffre designs, manufactures and markets innovative solutions for Baking, Food taste & pleasure, Health care and Biotechnology.
- Family group born in northern France in 1853, now a multi-national and a multicultural company, Lesaffre is committed to working with confidence to better nourish and protect the planet.
- In close collaboration with its clients and partners, Lesaffre employs 11 700 people in more than 50 countries.
Lesaffre achieves a turnover of 3,2 billion euros.
For over 30 years, Lesaffre has been involved in Human Health & Nutrition as part of its ambition to Better Nourish and Protect the Planet. In November 2018, Lesaffre acquired Gnosis Advanced Biotech and officially combined it with Lesaffre Human Care to form a new Business Unit named Gnosis by Lesaffre.
Gnosis by Lesaffre aims to raise the standard of human health and build a world where proactive health solutions empower people to live longer, happier lives.
By exploring the world of microorganisms, we tap into nature’s biological processes to develop solutions that address pressing health challenges while promoting positive impact on both human and planetary health.
Together with nutraceutical and pharmaceutical brands, we develop revolutionary products that help their customers thrive.
Our vision is a future where health is proactive, solutions are sustainable, and the timeless wisdom of nature guides every step forward.
Think like Nature to Raise human health.
Job Description
As a trusted advisor to the Gnosis China leadership team, the Regulatory Affairs Manager will:
- Demonstrates an unwavering commitment to Lesaffre's safety-first culture by strictly following all safety protocols and participating in required safety programs
- Drive regulatory strategy for China market access, leveraging global dossiers and local expertise.
- Provide authoritative guidance to cross-functional teams (sales, marketing, quality, medical affairs) on compliance, claims, and customer opportunities.
- Represent Gnosis externally with regulators, industry associations, and customers, in close collaboration with China Chief Regulatory Officer.
- Ensure two-way transparency with China Corporate teams, escalating risks and opportunities early to avoid misalignment.
- Develop market access & regulatory strategy
- Lead Gnosis China regulatory strategy and market access activities for ingredients and customer opportunities, identifying applicable regulatory pathways and requirements for each opportunity.
- Assess the regulatory status and marketability of ingredients in China, including applicable food standards, positive lists, food additive requirements, novel food ingredient requirements and other relevant regulatory frameworks.
- Leverage existing ingredient core dossiers and global regulatory data to assess China market access opportunities, identify data gaps and define pragmatic regulatory strategies.
- Support regulatory submissions, registrations, filings, notifications and technical documentation where required, coordinating with internal experts, customers and qualified external regulatory partners.
- Work closely with Global Gnosis regulatory team to optimize existing data, avoid duplication and facilitate consistent global market access strategies.
- Support claims development in collaboration with Gnosis medical affairs liaison.
- Assess proposed product, ingredient and customer-facing claims for compliance with China requirements, including the distinction between ordinary food claims, nutrition/functional statements and health food claims.
- Partner with scientific and medical affairs experts to evaluate available substantiation, identify regulatory risks and define compliant claim strategies for customers and commercial teams.
- Provide clear guidance on claims, labeling, advertising and promotional language, ensuring that disease prevention or treatment claims and other prohibited or misleading claims are not used.
- Provide regulatory guidance and support
- Interpret and apply China regulatory frameworks, standards and regulatory developments, ensuring alignment with global policies while tailoring implementation to China market requirements.
- Actively engage with China customers and commercial teams by providing practical regulatory guidance adapted to local market requirements and customer business needs.
- Advise customers on ingredient compliance, labeling, claims and supporting documentation in alignment with global frameworks and China requirements, while maintaining the appropriate boundaries of an ingredient supplier.
- Represent the regulatory function and provide tailored regulatory input to customer projects, product development, commercial opportunities and key account discussions.
- Participate in customer and key account meetings in China where regulatory expertise can support opportunity development, risk management or technical discussions.
- Develop relevant regulatory guidance documents for the China commercial team (e.g., Q&As, regulatory alerts and training materials).
- Actively participate in both the Global Regulatory operating rhythm and the China leadership cadence, ensuring two-way communication, knowledge sharing and alignment of local and global priorities.
- Build and maintain a strong, transparent partnership proactively sharing local regulatory intelligence, customer needs, risks, assumptions and opportunities and escalating material issues early.
- Ensure that local regulatory positions, commitments and customer guidance are consistent with agreed global positions, with clear documentation and transparent communication whenever local requirements require a different approach.
- Ensure regulatory impact assessment.
- Analyze the regulatory impact of changes to ingredients, specifications, manufacturing processes, dossiers, standards, claims or customer applications, including implications for China market access and customers.
- Build Gnosis regulatory intelligence dedicated to China.
- Maintain a strong understanding of the China regulatory landscape relevant to food ingredients, nutraceuticals, health foods, labeling, claims, advertising and market access.
- Develop a China regulatory watch as part of the Gnosis regulatory strategy and translate regulatory developments into actionable business implications, including relevant developments of applicable standards, and share key information through an agreed process.
- Develop insights through competitor analysis, customer interactions and external networks, identifying emerging regulatory trends that may affect the portfolio or customer opportunities.
- Partner with China commercial and marketing teams to use localized regulatory intelligence to shape compliant strategies that support customer needs and the company's market position.
- Share key findings from China market intelligence to contribute to regulatory strategies and decision-making across other markets.
- Ensure compliance of products in China.
- Review customer-facing and China commercial materials for regulatory accuracy, including claims, product descriptions, labeling-related content and other regulatory statements within the company’s scope.
- Support China compliance assessments and documentation aligned with local requirements and global regulatory standards.
- Promote transparent escalation of regulatory risks, uncertainties and potential non-compliance, ensuring appropriate involvement of Global Gnosis regulatory and Corporate Regulatory teams and other relevant functions.
- Develop external network.
- Represent the company, in collaboration and agreement with Lesaffre China Regulatory team, with relevant professional associations, regulatory experts and external stakeholders in China, contributing to a strong external regulatory network.
- Engage qualified local regulatory consultants, lawyers and technical experts when needed, ensuring external advice is documented, shared transparently and aligned with the company’s global regulatory position.
- Establish clear escalation and contact pathways for regulatory questions, ensuring customer and market issues are routed to the appropriate internal or external expert.
- Develop cross-functional collaboration & alignment
Act as the primary regulatory liaison for Gnosis China, ensuring transparent communication with:
- Global Gnosis Regulatory team (e.g., dossiers, global policies).
- Chief Regulatory Affairs Officer and the regulatory team, Greater China (e.g., government relations, cross-BU alignment).
Qualifications
- Bachelor’s degree in life sciences, food science, regulatory affairs, pharmacy, nutrition or related field (master’s preferred).
- 10-15 years of regulatory affairs experience in China, preferably in nutraceuticals, food ingredients, dietary supplements, consumer health or a related industry.
- Strong expertise in China food regulatory requirements, with demonstrated ability to navigate applicable SAMR, NHC, customs and food safety standard requirements.
- Hands-on experience with China market access for food ingredients and/or finished products, including assessment of food ingredient status, food additives, novel food ingredients, health food pathways and supporting technical documentation, as applicable.
- Strong understanding of China claims, labeling and advertising requirements, with practical experience assessing customer-facing claims and marketing materials.
- Deep understanding of how a premium ingredient supplier supports customer partners in regulatory compliance and market access while not holding direct accountability for finished product labels or customer regulatory decisions.
- Demonstrated ability to work effectively with other teams and other functions in a transparent, collaborative and globally aligned way.
- Demonstrated success advising senior leadership, commercial teams and cross-functional stakeholders on regulatory matters and business opportunities.
- Proven track record of managing regulatory projects, submissions, claims development and compliance across China and, preferably, multiple international markets.
- Strong ability to interpret and communicate scientific and regulatory information in a clear, pragmatic way for commercial application.
- Based in China (preferably Shanghai, or ….) with flexibility to travel (domestic and occasional international), including for customer meetings, regulatory interactions and global team meetings.
- Familiarity with Lesaffre’s business model (ingredient supplier vs. finished product manufacturer) and ability to navigate customer relationships while maintaining compliance boundaries.
- Experience working in a matrix organization, balancing local business needs with global regulatory alignment and able to work cross-functionally across China, European and other global time zones.
- Mandarin fluency required; strong professional English required for effective partnership with global teams.