Manager, Scientific & Regulatory Affairs | United States, Full-Time
Manus 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 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.
Why work at Manus:
- Opportunity – For motivated, results-oriented team members, our growth creates opportunities for personal and professional advancement.
- Accountability – You are given the resources you need to succeed and the freedom to make it happen; in return, we hold each other accountable for our high expectations.
- Passion – We love what we do and enjoy working with others who feel the same way. We embrace the challenge and hard work that comes with working on the cutting edge.
Core Responsibilities
Innovation
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.
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
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 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 both technical and business audiences.
- 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.
Additional Product Experience (Preferred)
The following experience is not required but would strengthen a candidate’s ability to support Manus’s expanded product portfolio in Agricultural Chemicals and Pharmaceutical Key Starting Materials:
- Experience with pesticide or agrochemical regulatory submissions, including EPA/FIFRA registrations, EU Regulation 1107/2009, or equivalent national frameworks.
- Familiarity with Drug Master File (DMF) or Active Substance Master File (ASMF) submissions, ICH Q7 GMP guidelines, and FDA/EMA requirements for pharmaceutical starting materials.
- Experience supporting regulatory strategy and stakeholder engagement across multi-sector portfolios spanning food, agricultural, and/or pharmaceutical markets.
- 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.
- Flexible with day-to-day duties and able to thrive in a start-up environment.
- Must uphold highest professional and ethical standards.
