Provide regulatory and scientific product support for technical regulatory projects. Interact with internal and external stakeholders to provide guidance regarding compliance with applicable food laws. Work with global, federal, state and local regulatory agencies and personnel on specific matters affecting food ingredients. Advise Kalsec on the regulatory trends and patterns that could affect registration progress.
Essential Job Functions:
- Drive results of assigned projects through application of regulatory science and strong communication and analytical skills. Conduct research and review of guidelines, regulatory precedence, and competitive intelligence to facilitate development of regulatory strategy for ingredient registrations. Prepare/review GRAS dossiers in support of registration and interact with consultants and relevant governmental bodies. Monitor, evaluate and generate scientific information and data to support safety for regulatory documentation, registration dossiers and risk assessment for products. Oversee strategic development and implementation of preclinical/clinical studies to support food ingredient safety. Interact with global government agencies to advance and secure ingredient approvals consistent with the company strategy. Conduct and review safety and tolerance assessments for investigational ingredients, novel foods and food ingredients. Provide regulatory support on all aspects of innovation pipelines and existing products and provide timely communication of regulatory and scientific events to business teams. Engage with scientific experts, external scientific organizations, and trade industry groups to advocate for science that supports our products. Review, navigate and advise globally on competent authority requirements, and scientific and industry positions that impact our portfolio. Participate in external scientific conferences; demonstrate thought leadership in the scientific and regulatory communities amongst customer and peer companies, and influential organizations. Maintain current knowledge of existing and emerging regulations, standards, and guidance documents and how they affect Kalsec products. Understand the implications of regional events that impact the product portfolio, including new legislation, global regulations, and emerging safety data. Track emerging science on new food safety risks, toxicological risk assessment methodologies and food safety issues relevant to Kalsec products. Develop effective operational plans and secure endorsement from key stakeholders, mobilizing the right resources to ensure successful execution. Contribute to and implement regulatory filing strategies as well as contribute responses to inquiries from regulatory authorities. Perform risk assessments on Kalsec ingredients and products for safety and regulatory limits based on internal and external scientific data.
- Determine whether and how to utilize internal or external technical resources.
- Review and interpret scientific literature and summarize effectively in writing. Manage budget specific to the assigned projects. Develop constructive and cooperative working relationships with others and maintain them over time. Work effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.
- PhD in Applied Biological Sciences, Nutrition, Food Science, Food Safety/ Toxicology, Public Health or other relevant subjects or equivalent combination of education and experience. 5-10+ years of experience in scientific and regulatory affairs, with experience in the food industry, or government food and agriculture regulation, and understanding of related issues. Proven successes in gaining global regulatory approvals for novel foods, food additives, GRAS substances, etc. Experience of the US, EU/ EFSA and Codex/ JECFA regulatory and risk assessment processes as minimum. Critical thinker with a strong ability to interpret science and communicate the impact and implications of potential regulations, to both technical and business audiences. Superior communication skills: ability to communicate complex scientific and technical regulatory issues related to food ingredients and consumer products. Proven experience and success across multiple cultures. Can build sustainable relationships with team members, internal partners, and nurture external relationships that deliver value for the business. Strong ability to influence and negotiate in a multi-cultural environment, across departments and sectors. A thought leader on best practices, scientific integrity, and transparency of working with an established network of contacts and external engagement profile with industry and influencers. Agility to be strategic when needed, but also to be fully engaged in day-to-day executional work. Technical know-how and ability with online systems for product data management. Ability to work cross functionally and lead meetings and teams. Must be detailed and accurate with strong demonstrated proof reading and reference checking skills. Knowledge of basic chemistry and mathematics. Ability to solve complex problems independently. Ability to work independently and collaboratively.
- Prior experience with flavor, food, pharma and/or allied industry documentation. Experience with ERP/MRP systems. Experience in global regulatory approvals of functional additives.