Manager, Scientific & Regulatory Affairs

MR Low country, LLC

Nebo, NC 28761 Telephone:  

The company works across industries and value chains to accelerate the transition to Bio Alternatives - better performing and more sustainable versions of complex molecules traditionally sourced from plants, animals, or fossil fuels. Our platform is proven to work across scales, bridging the Valley of Death between lab and manufacturing more efficiently and more reliably to deliver the benefits of synthetic biology today.

will be responsible for providing leadership, regulatory expertise, and support to our Natural products portfolio including the platforms for Sweeteners, Flavors, Fragrances, and consumer retail products across global markets. The Manager will manage, develop and implement regulatory strategies for innovative ingredients to obtain approvals and help ensure regulatory compliance across our product portfolio in global markets. As a thought leader, you will engage with regulatory authorities to progress the approval process and represent the company in SRA related trade industry organizations.

• Innovation:
  Monitor and evaluate and information and data to support safety for regulatory documentation, registration dossiers and risk assessment for products (initial emphasis on food ingredient regulation
  -low and no calorie natural sweeteners, and Natural Flavor & Fragrance ingredients - FEMA and IOFI).
• Oversee strategic development and implementation of preclinical/clinical studies to support food ingredient safety
• Support regulatory approval programs by coordination and compilation of documentation and timelines for FEMA, GRAS and/or novel food submissions, and approvals for expanded ingredient use in multiple regions.
• Interact with global government agencies to progress and secure ingredient approvals consistent with the commercial strategy.
• Coordinate internal teams to support implementation of regulatory strategies and ensure compliance with established plans.
• Facilitate and deliver clear and transparent toxicology risk assessment, enabling robust decision making based on updated scientific data and recognized risk assessment methods.
• Provide regulatory support on all aspects of innovation pipelines and existing products and provide timely communication of regulatory and scientific events to business team.
• Secure insights from various data sources, proactively leveraging knowledge to support corporate growth agendas.
• Leading internal cross-functional teams to provide strategic scientific and regulatory guidance, and clear recommendations to relevant internal partners and leadership forums on existing and emerging scientific and regulatory issues on food ingredients, packaging and related

• Engage with scientific experts, external scientific organizations, and trade industry groups to advocate for science that supports ingredients and products.
• Review, navigate and advise globally on competent authority requirements, and scientific and industry positions that impact the portfolio.
• Participate in external scientific forums when appropriate; demonstrate thought leadership in the scientific and regulatory community amongst customer and influential organizations.

• Understand the implications of regional events that impact the Industrial markets for the product portfolio, including new legislation, global regulations, emerging safety data, etc.
• Track emerging science on new food safety risks, toxicological risk assessment methodologies and food safety issues.
• Develop effective operational plans and secure endorsement from key stakeholders, mobilizing the right resources to ensure successful execution.
• Understanding of food regulations to ensure compliance on labeling
• Implement processes for the improvement of regulatory systems and documentation

• PhD/MS in Applied Biological Sciences, Nutrition, Food Science, Food Safety/ Toxicology, or other relevant subjects.
• 5-10+ years of experience in scientific and regulatory affairs, with experience in the food industry, or government food and agriculture regulation, and an understanding of related issues
• Proven successes in gaining global regulatory approvals for FEMA and GRAS substances, novel foods, food additives, flavor and fragrance materials.
• Experience on regulatory approvals of sweeteners would be beneficial.
• Experience of the US, EU/ EFSA and Codex/ JECFA…