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Regulatory Dossier Writer

Job in Norwich, Norfolk County, NR3, England, UK
Listing for: Man Diesel & Turbo Ltda
Full Time position
Listed on 2026-01-12
Job specializations:
  • Research/Development
    Research Scientist
  • Healthcare
Job Description & How to Apply Below

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…
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