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Job Description
MR Lowcountry, LLC. Nebo, NC 28761
Telephone:
843-628-5021 tom@mrlowcountry.com Manager, Scientific & Regulatory Affairs, Full-Time Aiken, SC area Hybrid to On-site The company works across industries and value chains to accelerate the transition to BioAlternatives - 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. The Manager, Scientific & Regulatory Affairs 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.
Core Responsibilities 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
External Engagement:
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.
Compliance:
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
Qualifications:
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 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. Strong attention to detail and technical writing skills for regulatory documentation and compilation First class communication skills; ability to communicate complex scientific and technical regulatory issues related to food ingredients and consumer products. Proven staff management experience and success across multi-cultures. Can build sustainable relationships with staff reports, 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. Experience of global risk assessment and approvals for natural, non and low-calorie sweeteners. 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 manage multiple tasks and meet deadlines in a fast-paced environment.
Preferred Working Style:
We seek a well-organized, self-motivated, creative individual who is able to both lead and manage multiple projects simultaneously. Must work independently, prioritize and be detail and deadline oriented with excellent time and project management skills. Must be a positive team member with a collaborative spirit who can navigate teams with ease. An entrepreneurial spirit with a passion for science and the food & flavor worlds. Ability to travel as needed to meet the job function Flexible with day-to-day duties and able to thrive in a start-up environment. Must uphold highest professional and ethical standards.
Other Duties:
Please note this job description does not fully describe or provide a comprehensive list of all duties and responsibilities of the position. Duties and responsibilities, including essential functions, may vary amongst locations and/or individuals holding this position and may be added or changed without notice. All qualified applicants will receive consideration for employment and will not be discriminated against based on race, color, religion, sex, sexual orientation, national origin, age, disability, or protected veteran status. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. We are an Equal Opportunity Employer M/F/Vets/Disability.
Benefits:
401(k) Dental insurance Health insurance Paid time off Relocation assistance Stock options Vision insurance
