Regulatory Dossier Writer

Regulatory Dossier Writer

IP & Regulatory – Norwich, Norfolk

Department

• IP & Regulatory

Employment Type

• Full-Time

Minimum Experience

• Mid-level

About the Role

Are you a plant scientist with expertise in molecular biology and/or gene-editing? Do you enjoy technical writing and applying your scientific knowledge outside of the laboratory? If so, Tropic is seeking a Regulatory Dossier Writer to join their international team.

As Tropic expands into new global territories, they are looking to add an additional Regulatory Dossier Writer to support their regulatory efforts.

Reporting to the Head of Regulatory, the Regulatory Dossier Writer will develop and submit regulatory dossiers to secure field trial permits and exemptions from GMO regulations for Tropic’s gene-edited products.

You will work within a cross-functional dynamic team, ensuring Tropic’s product development and commercialisation initiatives are enabled through successful regulatory approvals.

Job Purpose

The Regulatory Dossier Writer will:

• Create and manage regulatory dossiers for field trials of biotech crops and commercialisation of gene-edited products.
• Interpret complex scientific data and technical information, translating them into clear, accurate, and compliant regulatory documents.
• Collaborate effectively with cross-functional teams to support the development of innovative agricultural products.

Ideal Candidate Requirements:

• Strong expertise in plant biotechnology and gene editing technologies.
• A Commitment to or understanding of GMOs and gene-edited product regulations.
• Proven ability to write complex documents and effectively manage regulatory procedures.

Responsibilities

• Write, coordinate revisions and complete regulatory dossiers including:
  • Field trial permit applications
  • Exemption requests
  • Internal regulatory filings (e.g. self-determinations)
• Ensure documents align with Tropic’s regulatory strategy, adhering to complex regional requirements.
• Liaise with internal teams, external consultants, and regulatory bodies to gather data and streamline development and submission.
• Maintain compliance with global regulatory frameworks, including:
  • Content specifications
  • Terminology consistency
  • Appropriate formatting.
• Compile responses to regulator questions and requests for information, ensuring thorough revisions.
• Identify and mitigate regulatory challenges to expedite approvals.
• Stay updated on regulatory changes and industry standards to ensure compliance.
• Communicate progress and updates to stakeholders.
• Define and document dossier preparation, review, and submission processes.
• Organise and track:
  • Dossier development timelines
  • Critical post-submission activities
  • Approval progress.
• Maintain a central repository containing:
  • Document templates
  • Completed dossiers
  • Regulatory determinations
  • Approval letters.
• Support the preparation and execution of regulators’ meetings and ensure readiness for audits and inspections (e.g., Plant Breeding Innovation Management Program).