Regulatory Dossier Writer

Tropic Biosciences; Colney; On-site; GBP 35,000 - 55,000; Full time

Job summary

A leading agricultural biotechnology company in the UK is seeking a Regulatory Dossier Writer to develop and submit regulatory dossiers for gene-edited products. The role requires expertise in plant biology and biotechnology, excellent technical writing skills, and the ability to communicate effectively with stakeholders. Candidates should hold a PhD or MSc in a relevant field and have strong organizational and problem-solving skills. This position offers competitive compensation and benefits, as well as opportunities for career development.

Benefits

Private Medical Care

Medical Cash Plan

25 days annual leave

Life Assurance

Career development opportunities

Qualifications

• PhD degree or MSc (with 3 years experience) in relevant fields.
• Strong expertise in molecular biology and/or gene-editing.
• Excellent technical writing skills with formal document experience.

Responsibilities

• Write and coordinate regulatory dossiers and submissions.
• Ensure compliance with global regulatory frameworks.
• Liaise with external stakeholders for dossier development.

Skills

Plant biology and biotechnology

Technical writing

Regulatory requirements knowledge

Interpersonal skills

Organizational skills

Document management

Problem-solving

Education

PhD in Plant Biotechnology or related field

MSc with 3 years of relevant work experience

Tools

Microsoft Word

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 Tropic's gene-edited products. You will join a cross-functional dynamic team working to successfully enable Tropic's product development and commercialisation efforts.

• 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).
• 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.

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

• 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.

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.

• 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