Regulatory Science & Product Registration Lead (Seeds & Traits)

Position Overview

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.