Regulatory Science & Product Registration Lead (Seeds & Traits)

KingAgroot CropScience 清原作物科学; Campinas; Presencial; BRL 300 000 - 700 000; Tempo integral

Resumo da oferta

KingAgroot CropScience 清原作物科学 seeks a lead regulatory scientist to oversee GM crop dossiers, CTNBio submissions, and planned environmental releases in Brazil. The role blends strong molecular biology with process-driven regulatory strategy to draft technical rationales for NBTs and to align data for MAPA registration.

You will coordinate regulatory intelligence, manage CTNBio inquiries, and ensure compliance across RNC procedures, VCU trials, and biosafety approvals, interfacing with global R&D

Qualificações

• PhD or MSc with molecular genetics focus and extensive biotech regulatory experience in Brazil.
• Proven track record drafting CTNBio dossiers and handling official inquiries.
• Deep CTNBio regulatory understanding and data interpretation for risk assessment.

Responsabilidades

• Lead the preparation and assembly of scientific dossiers for commercial release and LPMAs.
• Draft precise, science-based responses to CTNBio inquiries and data requests.
• Support regulatory strategies for gene-edited products and NBTs.
• Oversee VCU trials and align data for MAPA registration (RNC).
• Monitor Latin American regulatory changes and interface with global R&D teams.

Conhecimentos

Molecular genetics

Technical writing

CTNBio knowledge

Regulatory strategy

NGS

Southern blot

RNC registration

Project management

English proficiency

Formação académica

PhD in Biotechnology, Biology or Agronomy

MSc with 8+ years relevant experience

Descrição da oferta de emprego

This role leads the technical writing, dossier compilation, and procedural management for genetically modified (GM) crops and gene-edited products (New Breeding Techniques - NBTs) in Brazil. The Lead will combine a process-driven mindset with solid scientific knowledge to draft regulatory submissions, manage Planned Environmental Releases (LPMAs), and author technical responses to CTNBio's official inquiries. Additionally, this position will drive regulatory intelligence and oversee VCU (Value for Cultivation and Use) trials required for variety registration with MAPA.

Key Responsibilities:

• Lead the preparation, technical writing, and assembly of scientific dossiers for commercial release and Planned Environmental Releases (LPMAs), ensuring full compliance with CTNBio standards.
• Act as the technical lead for analyzing and drafting precise, science-based responses to official inquiries and data requests from CTNBio members.
• Leverage a solid background in molecular biology to support regulatory strategies and technical rationales for gene-edited products, addressing official consultations for NBTs.
• Oversee the planning, data alignment, and administrative requirements for VCU (Valor de Cultivo e Uso) trials, ensuring the bridge between CTNBio biosafety approvals and National Cultivar Registration (RNC) with MAPA.
• Continuously monitor, analyze, and map changes in the Latin American regulatory landscape, competitive landscape (competitor pipeline), and evolving guidelines.
• Interface with global R&D teams to translate, adapt, and validate global data into the standard format required by Brazilian authorities.

Qualifications

• PhD in Biotechnology, Biology or Agronomy, with minimum of 5 years relevant experience; MSc with minimum of 8 years relevant experience with a focus on molecular genetics.
• Proven experience in technical writing for biotechnology regulatory affairs in Brazil. Demonstrated track record in drafting CTNBio dossiers and handling official inquiries.
• Deep, process-oriented understanding of CTNBio requirements, with solid experience evaluating complex molecular characterization data. This includes hands-on familiarity with southern blot analysis, next-generation sequencing (NGS), flanking sequences, allergenicity/toxicity profiles, and food/feed/environmental risk assessment data packages.
• Familiarity with MAPA’s administrative and legal frameworks, specifically regarding VCU (Valor de Cultivo e Uso) trial protocols, data alignment, and RNC (Registro Nacional de Cultivares) registration procedures to ensure the smooth transition from biosafety approval to commercial seed licensing.
• Attention to quality and detail-oriented.
• Efficient and timeline driven.
• Excellent oral and written communication (including presentation) skills.
• Fluent in English and Portuguese is required for scientific data review and alignment with global R&D teams.