Manager, Scientific & Regulatory Affairs

Manager, Scientific & Regulatory Affairs | United States, Full-Time

Manus 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 biotechnology today.

The Manager, Scientific & Regulatory Affairs will be responsible for providing regulatory expertise and support to our Natural products portfolio including Sweeteners, Flavors, Fragrances, Agricultural Chemicals, and Pharmaceutical Key Starting Materials. The Manager will manage, develop and implement regulatory strategies for innovative ingredients to obtain approvals in global markets. As a thought leader, you will engage with regulatory authorities to progress the approval process and represent Manus in SRA related trade industry organizations.

Monitor and evaluate 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
• Interact with global government agencies to progress and secure ingredient approvals consistent with the commercial strategy.
• 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.

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

• 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 GRAS substances, novel foods, food additives, Flavor and Fragrance materials and expanded ingredient use in multiple regions.
• Experience on regulatory approvals of sweeteners would be beneficial.
• Experience of the US, EU/ EFSA and Codex/ JECFA regulatory and risk assessment processes as minimum; familiarity with EPA/FIFRA and EU Reg. 1107/2009 for agricultural chemicals, and ICH Q7 GMP guidelines and FDA/EMA requirements for pharmaceutical starting materials, also desirable.
• Strong attention to detail and technical writings skills for regulatory documentation and compilation.
• Critical thinker with a strong ability to interpret science and communicate the impact and implications of potential regulations, to…