Manager, Scientific & Regulatory Affairs

Manus Bio

Augusta, GAFull-timeNo compensation foundPosted 2mo agoVerified open 5 days ago

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At a glance

Compensation

No compensation found

Location

Augusta, GA

Schedule

Full-time

Work Authorization

Not specified

Requirements

Credentials this posting asks for.

Doctorate

Job overview

Manus Bio is hiring a Manager, Scientific & Regulatory Affairs. The Manager, Scientific & Regulatory Affairs at Manus Bio provides regulatory expertise and support for natural product portfolios, overseeing strategy development, global approvals, and risk assessments while engaging with authorities and industry groups to drive innovative ingredient commercialization.

Key focus areas include Monitor and evaluate information and data to support safety for regulatory documentation, Oversee strategic development and implementation of preclinical/clinical studies, and Interact with global government agencies to secure ingredient approvals.

Successful candidates bring PhD In Applied Biological Sciences Or Related Field, 5-10+ Years Scientific And Regulatory Affairs Experience, and Experience In Food Industry Or Government Food And Agriculture Regulation. Important skills include Regulatory Expertise, Regulatory Strategy Development, Regulatory Strategy Implementation, Thought Leadership, Monitoring And Evaluation, and Risk Assessment. Preferred (not required): Pesticide Or Agrochemical Regulatory Submissions, EPA/FIFRA Registrations, EU Regulation 1107/2009, and Drug Master File Submissions.

Skills & qualifications

RequiredNice to have

Skills

Regulatory ExpertiseRegulatory Strategy DevelopmentRegulatory Strategy ImplementationThought LeadershipMonitoring and EvaluationRisk AssessmentFood Ingredient RegulationPreclinical/Clinical Study OversightRegulatory SupportLeveraging KnowledgeAdvising on Competent Authority RequirementsUnderstanding of Food RegulationsOperational Plan DevelopmentDocumentationProblem SolvingInterpreting ScienceCommunicationStaff ManagementBuilding Sustainable RelationshipsInfluenceNegotiationScientific IntegrityTransparencyStrategic ThinkingDay-to-Day Executional WorkOnline Systems for Product Data ManagementPesticide or Agrochemical Regulatory SubmissionsEPA/FIFRA RegistrationsEU Regulation 1107/2009Drug Master File SubmissionsActive Substance Master File SubmissionsICH Q7 GMP GuidelinesFDA/EMA Requirements for Pharmaceutical Starting MaterialsStakeholder ManagementWell-OrganizedSelf-MotivatedCreativeLead Multiple ProjectsManage Multiple ProjectsWork IndependentlyTime ManagementDetail-OrientedDeadline-OrientedProject ManagementPositive Team MemberCollaborative SpiritEntrepreneurial SpiritPassion for SciencePassion for Food & Flavor WorldsEngaging With Regulatory AuthoritiesSRA Related Trade Industry OrganizationsMonitoring Information and DataEvaluating Information and DataPreclinical/Clinical Studies OversightInteracting With Global Government AgenciesRegulatory Support for Innovation PipelinesRegulatory Support for Existing ProductsSecuring Insights From Data SourcesEngaging With Scientific ExpertsEngaging With External Scientific OrganizationsEngaging With Trade Industry GroupsReviewing Competent Authority RequirementsNavigating Competent Authority RequirementsParticipating in External Scientific ForumsThought Leadership in Scientific and Regulatory CommunityUnderstanding Regional Events Impacting Industrial MarketsTracking Emerging Science on Food Safety RisksTracking Food Safety IssuesDeveloping Operational PlansFood RegulationsAttention to DetailInfluencingNegotiatingAgilityRegulatory Strategy Across Multi-Sector PortfoliosStakeholder Engagement Across Multi-Sector PortfoliosOverseeing Strategic Development of Preclinical/Clinical StudiesFacilitating Toxicology Risk AssessmentDelivering Toxicology Risk AssessmentTimely Communication of Regulatory EventsTimely Communication of Scientific EventsLeveraging Knowledge for Corporate GrowthUnderstanding Implications of Regional EventsTracking Toxicological Risk Assessment MethodologiesUnderstanding Food RegulationsCommunicating Impact of Potential RegulationsCommunicating Implications of Potential RegulationsGlobal Risk AssessmentTechnical Know-How With Online SystemsProduct Data ManagementPesticide Regulatory SubmissionsAgrochemical Regulatory SubmissionsFDA Requirements for Pharmaceutical Starting MaterialsSafety AssessmentInteraction With Global Government AgenciesUnderstanding Regional EventsTracking Emerging ScienceGlobal Approvals for Natural SweetenersGlobal Approvals for Non-Calorie SweetenersDay-to-Day ExecutionProduct Data Management SystemsCreativityGRAS SubstancesNovel FoodsFood AdditivesFlavor MaterialsFragrance MaterialsEPAFIFRAEFSACodexJECFAFDAEMADMFASMFToxicologyRegulatory DocumentationScientific WritingOnline Product Data Management SystemsPharmaceutical Starting Materials Regulatory StrategyFEMAIOFICodex/JECFAEPA/FIFRAICH Q7 GMPFDA/EMAGRASStrong Attention to DetailFirst Class CommunicationInfluence and NegotiationStrategic AgilityTechnical Know-How With Online Product Data Management SystemsFlexibleGRAS Regulatory KnowledgeFDA Regulatory KnowledgeEMA Regulatory KnowledgeEU EFSA Regulatory KnowledgeCodex JECFA Regulatory KnowledgeEPA FIFRA KnowledgeEU Regulation 1107/2009 KnowledgeICH Q7 GMP KnowledgeDMF Submission KnowledgeASMF Submission KnowledgeOrganizational SkillsSelf MotivationCreative Problem SolvingRegulatory Strategy and Stakeholder Engagement Across Multi‑Sector PortfoliosRegulatory StrategyData Management SystemsFDA EMA KnowledgeFEMA KnowledgeIOFI KnowledgeIndependent WorkPesticide Agrochemical Regulatory SubmissionsDMF ASMF SubmissionsEU EFSADrug Master File (DMF)Active Substance Master File (ASMF)Risk Assessment MethodologiesLeadershipMulticultural Team ManagementGlobal Regulatory ApprovalsGRAS Substances KnowledgeNovel Foods KnowledgeFood Additives KnowledgeFlavor and Fragrance Materials KnowledgeSweeteners Regulatory ExperienceFood Regulations UnderstandingToxicology Risk AssessmentCommunication SkillsRegulatory AffairsFood Safety RegulationsToxicology KnowledgeData AnalysisUS Regulatory ProcessesEU/EFSA Regulatory ProcessesCodex/JECFA Regulatory ProcessesEU Reg. 1107/2009FDA/EMA RequirementsDMF SubmissionsASMF SubmissionsRegulatory ApprovalsProfessional EthicsCollaborative TeamworkRegulatory Approvals of SweetenersRegulatory Strategy and Stakeholder EngagementRegulatory Affairs ExpertiseFood Safety Regulations KnowledgeICH Q7 GMP Guidelines KnowledgeFDA/EMA Requirements KnowledgeCodex JECFA Processes KnowledgeMulti‑Cultural Relationship BuildingFood Regulations KnowledgeGRAS KnowledgeFDA KnowledgeEMA KnowledgeEU EFSA KnowledgeCodex KnowledgeJECFA KnowledgePesticide or Agrochemical Regulatory Submissions ExperienceDrug Master File KnowledgeActive Substance Master File KnowledgeMulti-Sector Portfolio Regulatory StrategyFood Safety RegulationGRAS Substance ApprovalNovel Foods ApprovalFlavor and Fragrance RegulationAgricultural Chemical RegulationPharmaceutical Starting Materials RegulationCross‑Cultural ManagementRisk Assessment ProcessesIndependentCollaborativeEthical StandardsPreclinical Clinical Study ManagementGRAS Regulatory ApprovalsNovel Foods ApprovalsFood Additives ApprovalsFlavor Fragrance Regulatory KnowledgeAgricultural Chemicals RegulationInfluence NegotiationCross Cultural Team LeadershipAgility Strategic ThinkingDetail Deadline OrientationAdaptabilityProfessional Ethical StandardsUS EU EFSA Codex JECFA Processes KnowledgeSweetener Regulatory Approvals ExperiencePesticide Agrochemical Regulatory Submissions ExperienceDrug Master File Submissions KnowledgeICH Q7Online Product Data ManagementLabelingPharmaceutical Regulatory StrategyFood Ingredient Regulation KnowledgeRegulatory Authority EngagementScientific InterpretationGlobal Regulatory Framework NavigationPesticide Regulatory Submissions ExperienceDMF ASMF Submission FamiliarityMulti‑Sector Portfolio Strategy SupportWell‑Organized Self‑Motivated CreativeCollaborative Team MemberFlexibility in Start‑Up EnvironmentFDA RegulationsEMA RegulationsEFSA RegulationsCodex RegulationsJECFA RegulationsEPA/FIFRA RegulationsDMF Submissions KnowledgeASMF Submissions KnowledgeCross‑Cultural LeadershipFDA RequirementsEMA RequirementsCodex StandardsJECFA StandardsFEMA StandardsIOFI StandardsTeam CollaborationSweetener Regulatory ApprovalsEU EFSA RegulationsToxicology StudiesFlavor and Fragrance MaterialsLabeling ComplianceTechnical DocumentationCross‑Cultural CommunicationRegulatory Agency EngagementScientific Thought LeadershipFDA Regulations KnowledgeEMA Regulations KnowledgeCodex JECFA KnowledgeDMF KnowledgeASMF KnowledgeAgricultural Chemical Regulations KnowledgePharmaceutical Starting Materials Regulations KnowledgeMulti‑Cultural CollaborationOrganizedAgileScientific ExpertiseRegulatory Documentation WritingGlobal Regulatory Strategy DevelopmentData Management Systems ProficiencyUS Food Regulation KnowledgeEU EFSA Regulation KnowledgeCodex JECFA Regulation KnowledgeDrug Master File Submissions ExperienceMulti‑Sector Portfolio Regulatory Strategy ExperiencePreclinical Clinical OversightRegulatory SubmissionsFlavor Fragrance MaterialsSweetener ApprovalsJECFA GuidelinesGRAS Substance ApprovalsInfluencing and NegotiationEmerging Science TrackingGlobal Regulatory Approvals for GRAS SubstancesUS Regulatory and Risk Assessment ProcessesEU/EFSA Regulatory and Risk Assessment ProcessesCodex/JECFA Regulatory and Risk Assessment ProcessesGlobal Risk Assessment for SweetenersTechnical CommunicationGRAS Regulatory SubmissionsCross‑Functional LeadershipCodex JECFA RegulationsAgriChem Regulatory Submissions

Qualifications

PhD/MS in Applied Biological SciencesPhD/MS in NutritionPhD/MS in Food SciencePhD/MS in Food Safety Toxicology5-10+ Years Scientific Regulatory Affairs ExperienceExperience in Food IndustryExperience With Global Regulatory ApprovalsExperience With Sweetener ApprovalsExperience With US EU EFSA Codex JECFA ProcessesFamiliarity With EPA FIFRAFamiliarity With ICH Q7 GMP GuidelinesFamiliarity With FDA EMA Requirements

Full job description

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. 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.
Flexible with day-to-day duties and able to thrive in a start-up environment.
Must uphold highest professional and ethical standards.

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