Regulatory Dossier Writer

Man Diesel & Turbo Ltda; Greater London; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading agricultural biotechnology company is seeking a Regulatory Dossier Writer to develop and manage regulatory documents for gene-edited products. The ideal candidate will hold a PhD in a relevant field and possess strong technical writing skills, along with expertise in plant biology and regulatory requirements. This role involves liaising with internal teams and external bodies to ensure compliance with global regulations, contributing to innovative agricultural solutions to enhance food security.

Benefits

Private Medical Care

Medical Cash Plan

25 days annual leave

Life Assurance

Career development opportunities

Social events throughout the year

Qualifications

• PhD in Plant Biotechnology, Plant Molecular Biology, Agricultural Science, or related fields.
• 3+ years of relevant work experience in agriculture or biotech.

Responsibilities

• Write and coordinate regulatory dossiers for field trials.
• Ensure compliance with regulations for GMO products.
• Liaise with teams for information and dossier development.
• Compile answers to regulator queries.
• Identify regulatory challenges and propose solutions.

Skills

Plant biology expertise

Regulatory knowledge

Technical writing

Interpersonal skills

Attention to detail

Project management

Problem-solving

Education

PhD in Plant Biotechnology or related field

MSc with 3 years' experience

Tools

Microsoft Word

Document management systems

Job description

Are you a plant scientist with expertise within molecular biology and/or gene-editing? Do you enjoy technical writing and applying your scientific knowledge outside of the laboratory? Are you interested in joining a fast-paced, innovative agricultural biotechnology company as a Regulatory Dossier Writer?

A new growth opportunity has just opened up at Tropic within our Regulatory function. Reporting to the Head of Regulatory, the Regulatory Dossier Writer will play a crucial role in developing and submitting regulatory dossiers to secure field trial permits and exemptions from GMO regulations for Tropics gene‑edited products. You will join a cross‑functional dynamic team working to successfully enable Tropics 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 Tropics 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 regulator 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 organised 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).

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 the 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 organisational, 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 to project requirements, commercial activities, the regulatory authority involved, and/or changes in the regulatory landscape and guidelines.

Desirable Skills

• Fluency in Spanish (highly desirable).
• 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.

About Us

Tropic is one of the world’s leading agricultural gene‑editing companies. Our team is dedicated to the development and commercialisation 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 Care, Medical Cash Plan
• 25 days annual leave and Life Assurance

Further Information

• Job Location Norwich UK (onsite or hybrid)
• Time Requirement Full Time
• Contract Permanent
• Closing date 8/1/2026