Regulatory Affairs Manager
- Contract type: Permanent Contract
- Years of experience: 5 to 10 years
- Activity: Human care
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.
About Gnosis by Lesaffre
At Gnosis by Lesaffre, we harness the power of microorganisms to transform compounds into usable nutritional actives, probiotics, and nutritional and functional yeasts that benefit human wellbeing. We strive to create a world that moves better, digests better, ages better, feels better, and ultimately, lives better thanks to microorganisms and biotransformation.
At Gnosis by Lesaffre APAC, we are looking for a talented, dynamic and enthusiast Regulatory Affairs Manager to support the development of our business across the region. You will be reporting to the APAC Regulatory Affairs Team Manager.
- Manage timely regional registration activities.
- Ensure product compliance with local regulations.
- Develop and implement regional regulatory strategies in collaboration with relevant stakeholders.
- Provide regulatory strategic input to global R&D projects.
- Provide regulatory guidance and advice to marketing and APAC sales teams.
- Conduct regulatory watch and monitor local legislation development which may affect Gnosis by Lesaffre products.
- Work closely with regulatory colleagues to maintain knowledge in country and product-specific regulatory requirements.
- Build effective working relationships with other departments of Gnosis and Lesaffre.
- Knowledge in food/food supplements or pharma regulations across APAC.
- Knowledge of regulatory landscape in Korea, Japan and/or China is a strong plus.
- Good organizational and communication skills.
- Ability to work independently.
- Result and customer oriented with creative problem solver mindset.
- Team player with good interpersonal skills.
- Experience in project management appreciated, however project management course will be offered.
- Good written and verbal communication skills.
- Fluent in English. Chinese, Korean and/or Japanese is a plus.
Education and experience
- Master’s degree or equivalent in Science, Pharmacy or related scientific discipline.
- 5 years of regulatory experience in healthcare / food / pharmaceutical industry.