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.
Overview
At Gnosis by Lesaffre APAC, we are looking for a talented, dynamic, and motivated Regulatory Affairs Specialist to support the expansion of our business in APAC. Reporting to the APAC Senior Regulatory Affairs Manager, you will be responsible for the regulatory compliance of our product portfolio and play a critical role providing strategic advice on regulatory risks and opportunities to support market growth and innovation in APAC.
CORE SAFETY ROLES & RESPONSIBILTIES
- Comply with local governmental HSE regulations, with Lesaffre fundamental principles and apply the safety Policy,
- Participate in entity safety activities and always show best examples (Rules application, PPE wearing, perform safety visits, accident analysis, safety committees…),
- Participate actively in the risk assessment of own’s job area
- Follow the safety action plan of own perimeter,
- Make safety rules in your perimeter, communicate it, make sure your team understands and applied them,
- Start all meetings (from 8 persons minimum) by a safety contact,
- Encourage safe acts and discourage each time you see unsafe acts,
- Report unsafe conditions / acts and near misses to the managers,
- Report within 12 hours all recordable accidents to the next level of management,
- Report each month all recordable accidents and first aids happened in your perimeter,
- Participate in the target-setting process for the safety KPIs,
- Be a part of recognition & sanction program.
HSE ROLES AND RESPONSIBILITIES FOR REGULATORY AFFAIRS
The person in charge of the entity legal affairs is responsible for:
- Integrate HSE requirements into all concerned contractors’ contracts,
- keeps a HSE regulatory watch and communicates it.
MAIN RESPONSIBILITIES
- Ensure compliance of assigned Gnosis’ product portfolio with local regulations,
- Manage timely regional registration activities, including registration dossier preparation and proper documentation of submitted documents,
- Execute regional regulatory strategies in line with the global strategic plan,
- Provide regulatory guidance and advice to internal stakeholders (e.g. marketing, R&D),
- Conduct regulatory watch and monitor changes in local legislation landscape, assess the impact towards Gnosis’s product portfolio and communicate accordingly to internal stakeholders,
- Build effective working relationships with internal stakeholders,
- Work closely with regulatory colleagues to maintain knowledge in APAC countries and product-specific regulatory requirements,
- Maintain full awareness of regulatory activities of assigned portfolio and provide regular reports.
Qualifications
- Knowledge in food/food supplements across APAC, experience in Korean food regulations is a plus,
- Good organizational skills, possess structured approach to working tasks,
- Collaborative team player with the ability to work independently,
- Experience in project management appreciated, however project management course will be offered,
- Comfortable working in an international fast paced environment,
- Good written and verbal communication skills,
- Fluent in English, Korean is a plus.
Education and experience
- Bachelor’s degree or equivalent in Science, Pharmacy or related scientific discipline
- Minimum of 2 years of regulatory experience in healthcare or food industry.
