PLEASE NOTE - THIS ROLE IS INTERNAL ONLY The Regulatory Dossier Manager will play a crucial role in managing the development and submission of regulatory dossiers to secure field trial permits and exemptions from GMO regulations for Tropic’s gene-edited products. They will join a cross-functional dynamic team working to successfully enable Tropic’s product development and commercialisation efforts. Job Purpose The Regulatory Dossier Manager will create and manage the development of dossiers required to gain regulatory approvals to conduct field trials of biotech crops and to commercialise gene-edited products. They will interpret complex scientific data and other technical information, translating them into clear, accurate and compliant regulatory documents. The ideal candidate will possess strong expertise in plant biotechnology and gene editing technologies, strong interest in and understanding of regulations relating to GMOs and gene-edited products along with a proven ability to write and manage complex documents while working cross-functionally to support the development of innovative agricultural products. Responsibilities · Write and coordinate the revision and completion of dossiers such as field trial permit applications, exemption requests and regulatory internal filings (e.g., self-determinations). · Ensure regulatory dossiers align with Tropic’s regulatory strategy, including navigating complex regulatory requirements in different regions. · Liaise with internal teams, external consultants, and regulatory bodies to gather all relevant information and to facilitate efficient dossier development and submission. · Ensure all documents are complete, accurate and in compliance with relevant global regulatory frameworks, including content specifications, terminology and formatting. · Compile, develop and manage the revision and submission of answers to regulators’ questions and requests for further information. · Identify and propose solutions to regulatory challenges, ensuring smooth progression through the submission and approval process. · Stay updated on changing regulatory requirements and industry best practices to ensure dossiers are always in compliance. · Clearly communicate and report progress and relevant updates to internal and external stakeholders. · Define and document processes for effective management of dossier development, revisions, and internal records. · Maintain an organized system for tracking dossier development and submission timelines, key post-submission activities and approvals. · Maintain a repository of all relevant regulatory documents including document templates, dossiers, regulatory determinations and approval letters. · Contribute to the preparation and execution of meetings with regulators and regulatory audits and inspections (e.g., Plant Breeding Innovation Management Program). Requirements Qualifications: · PhD degree (or MSc degree with at least 3 years of relevant work experience) in Plant Biotechnology, Plant Molecular Biology, Agricultural Science, or related fields. Essential skills: · Strong expertise in plant biology and biotechnology, molecular biology and/or gene-editing technologies applied in agriculture. · Familiarity with global regulatory requirements for biotech crops. · Excellent technical writing skills, with ability to present complex regulatory information clearly and demonstrated experience delivering high quality formal documents. · Proficiency with software tools for document preparation, such as Microsoft Word. · Strong interpersonal skills and ability to clearly communicate with subject matter experts, regulatory stakeholders, and internal teams to gather information, ensure alignment on requirements and provide updates on progress. · Excellent attention to detail and ability to ensure that scientific data is accurately presented and that all regulatory guidelines and formatting standards are followed. · Strong critical thinking skills and effective problem-solving with ability to identify gaps or misalignments in regulatory data or documents and address them in a regulatory-appropriate manner. · Strong organizational, planning and project management skills to effectively manage multiple priorities and meet deadlines. · Ability to work independently and collaboratively as part of a cross-functional dynamic team in a fast-paced environment. · Resilience and flexibility to adjust dossier preparation according project requirements, commercial activities, the regulatory authority involved, and/or changes in the regulatory landscape and guidelines. Desirable skills: · Direct work experience in agricultural biotechnology or gene editing. · Experience creating and managing regulatory dossiers. · Knowledge of biosafety, environmental impact assessments, and food safety considerations for biotech crops. · Experience with document management systems and processes. · Fluency in Spanish. About Us Tropic is one of the world’s leading agricultural gene-editing companies. Our team is dedicated to the development and commercialization of high-performing varieties of tropical crops to provide significant benefits to growers, processors and consumers globally, tackling real-world problems around food security and sustainability. Our vision is to become a leading seed business with significant ownership of its products from the laboratory to the field, while maintaining constructive relationships with growers and consumers based on transparency and trust. Why Join Tropic? Diverse workforce operating in a dynamic working environment Excellent learning and career development opportunities Social events throughout the year Competitive compensation and benefits including: Private Medical Insurance, Medical Cash Plan, 25 days annual leave, Group Income Protection and Life Assurance Further Information Job Location – Norwich UK Time Requirement – Full Time Contract – Permanent Closing date –