Manager, Scientific & Regulatory Affairs

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 advancementAccountability 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 expectationsPassion 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 preclinicalclinical studies to support food ingredient safetyInteract with global government agencies to progress and secure ingredient approvals consistent with the commercial strategyFacilitate and deliver clear and transparent toxicology risk assessment enabling robust decision making based on updated scientific data and recognized risk assessment methodsProvide regulatory support on all aspects of innovation pipelines and existing products and provide timely communication of regulatory and scientific events to business teamSecure insights from various data sources proactively leveraging knowledge to support corporate growth agendasExternal 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 portfolioParticipate in external scientific forums when appropriate; demonstrate thought leadership in the scientific and regulatory community amongst customer and influential organizationsCompliance 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 issuesDevelop effective operational plans and secure endorsement from key stakeholders mobilizing the right resources to ensure successful executionUnderstanding of food regulations to ensure compliance on labelingQualifications PhDMS in Applied Biological Sciences Nutrition Food Science Food SafetyToxicology or other relevant subjects5 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 issuesProven successes in gaining global regulatory approvals for GRAS substances novel foods food additives Flavor and Fragrance materials and expanded ingredient use in multiple regionsExperience on regulatory approvals of sweeteners would be beneficialExperience of the US EU EFSA and Codex JECFA regulatory and risk assessment processes as minimum; familiarity with EPAFIFRA and EU Reg 11072009 for agricultural chemicals and ICH Q7 GMP guidelines and FDAEMA requirements for pharmaceutical starting materials also desirableStrong attention to detail and technical writings skills for regulatory documentation and compilationCritical thinker with a strong ability to interpret science and communicate the impact and implications of potential regulations to both technical and business audiencesFirst class communication skills; ability to communicate complex scientific and technical regulatory issues related to food ingredients and consumer productsProven 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 businessStrong ability to influence and negotiate in a multi cultural environment across departments and sectorsExperience of global risk assessment and approvals for natural non and low calorie sweetenersA thought leader on best practices scientific integrity and transparency of working with an established network of contacts and external engagement profile with industry and influencersAgility to be strategic when needed but also to be fully engaged in day to day executional workTechnical know how and ability with online systems for product data managementAdditional Product Experience Preferred The following experience is not required but would strengthen a candidates ability to support Manuss expanded product portfolio in Agricultural Chemicals and Pharmaceutical Key Starting Materials Experience with pesticide or agrochemical regulatory submissions including EPAFIFRA registrations EU Regulation 11072009 or equivalent national frameworksFamiliarity with Drug Master File DMF or Active Substance Master File ASMF submissions ICH Q7 GMP guidelines and FDAEMA requirements for pharmaceutical starting materialsExperience supporting regulatory strategy and stakeholder engagement across multi sector portfolios spanning food agricultural andor pharmaceutical marketsPreferred Working StyleWe seek a well organized self motivated creative individual who is able to both lead and manage multiple projects simultaneouslyMust work independently prioritize and be detail and deadline oriented with excellent time and project management skillsMust be a positive team member with a collaborative spirit who can navigate teams with easeAn entrepreneurial spirit with a passion for science and the food & flavor worldsFlexible with day to day duties and able to thrive in a start up environmentMust uphold highest professional and ethical standards