Calyxt is seeking a highly motivated and result-oriented Senior Regulatory Scientist to join our Regulatory organization. The successful candidate will have an opportunity to work in a team environment and interact with experts in molecular biology, gene editing, plant transformation, regulatory, commercial, breeding and supply chain. The individual will be responsible for developing Regulatory product strategies and coordinating Regulatory studies for Calyxt’s rich product pipeline. This includes product safety studies, regulatory submissions, label claims to ensure compliance and competitivity of Calyxt products at each Product Development phase. S/he will have a unique opportunity to work with cross-functional teams as Calyxt gene edited products progress through the R&D pipeline, comply with regulatory requirements, and are brought to commercialization.
- Lead the development of nutrition and ingredient label declarations that are required per US FDA regulations and help to maintain Calyxt’s competitive edge by ensuring accuracy and timeliness while enabling Calyxt’s innovative approach.
- Drive improvements and standardization across the phases of product development for new Calyxt crops such as hemp in order to ensure high regulatory standards while maintaining optimal speed to market and efficient use of
- Support Calyxt’s Identity-Preserved Process and ensure continuous improvement with engagement from key
- Work in collaboration with the R&D, Breeding, and Commercial teams to ensure Regulatory compliance for activities related to seed quality and storage, product Phase advancement and defining Regulatory paths to
- Write regulatory submissions for US authorities, or other global authorities as needed, to ensure Calyxt’s products comply with local requirements while enabling timely product
- Participate in implementation and maintenance of product stewardship program across product develop phases so as to ensure regulatory compliance and product sustainability.
- Travel up to 15% both domestic and international.
- Minimum of a Master of Science degree (preferably PhD degree) in a food science, biological science or related field (Bachelor degree with 15 years of applicable experience will also be considered).
- Minimum of 5-7 years food or related industry experience, corporate or government regulatory experience in food labeling or solid background in nutrition related
- Good understanding of US Food and Drug Administration labeling regulations to assure the accuracy of ingredient statements, nutrition facts, allergen declarations and claims. Ability to monitor, interpret and ensure compliance with US
- Solid organizational and time management skills to ensure successful and timely documentation and completion of
- Demonstrated leadership in developing regulatory strategies and obtaining timely product
- Good understanding or hands-on experience with R&D technologies in agricultural biotechnology and/or food
- Excellent verbal and written communication skills and the ability to work in a team environment to achieve project
- Ability and willingness to be hands-on as well as sense of urgency
- Experience in non-GMO product
- Product development