Bionema Group Limited
Regulatory Affairs Specialist
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Regulatory Affairs Specialist
đź“Ť Swansea, UK
đź’Ľ Full-time, on-site
đź“… Immediate start
💷 £45,000–£90,000, depending on experience
About Bionema
Bionema Group is a UK biological crop protection platform company developing microbial biopesticides supported by proprietary formulation and delivery technologies. These include Incapsulex® microencapsulation, Adhesulex™ biosurfactant technology, and BiofilmTech™ microbial technology, designed to improve product stability, delivery, field performance, and commercial scalability.
Since 2012, Bionema has taken biological technologies from laboratory development through formulation, field validation, and commercialisation. In 2021, Syngenta acquired two Bionema products and supporting technology. Our work has also been recognised with two King’s Awards for Enterprise.
About the Role
We are seeking a Regulatory Affairs Specialist to develop and execute regulatory strategies for Bionema’s microbial biopesticide pipeline across the UK and international markets.
This is a commercially important role. You will determine regulatory pathways, identify evidence requirements, coordinate studies, and prepare submissions that move products from development towards registration and market entry.
You will work closely with Bionema’s R&D, quality, and commercial teams to ensure regulatory requirements are built into product development from the outset.
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Key Responsibilities
- Develop regulatory strategies for microbial active substances and formulated biological plant protection products
- Determine product classification, registration pathways, and data requirements for target markets
- Prepare, review, and maintain regulatory dossiers, technical files, and submission documentation
- Conduct data-gap assessments and support the planning and commissioning of regulatory studies
- Coordinate submissions and communications with regulatory authorities, laboratories, consultants, and other external partners
- Review product labels, technical literature, and marketing claims for regulatory compliance
- Monitor changes in UK, European, and international plant protection regulations
- Maintain regulatory records, submission timelines, and product documentation
- Support regulatory due diligence for licensing, distribution, and commercial partnerships
What You Will Bring
- Demonstrable regulatory affairs experience within plant protection, biopesticides, agrochemicals, biotechnology, or a closely related sector
- Hands-on experience preparing or coordinating regulatory dossiers and technical submissions
- Strong knowledge of UK and European plant protection regulatory requirements
- Ability to interpret scientific data covering product identity, analytical methods, efficacy, toxicology, ecotoxicology, environmental fate, and residues, where applicable
- Strong technical writing, project management, and attention to detail
- Ability to work effectively across scientific, quality, and commercial teams
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Desirable
- Degree in biological sciences, agriculture, environmental science, chemistry, regulatory affairs, or a related discipline
- Experience with microbial active substances or biological plant protection products
- Experience working with regulatory authorities, contract research organisations, or specialist consultants
- Experience supporting product registrations across multiple international markets
Why Join Bionema?
You will play a direct role in advancing Bionema’s microbial biopesticide pipeline towards registration and commercialisation, with the opportunity to influence regulatory strategy across several proprietary products and technology platforms.
How to Apply
Send your CV and a short covering letter to info@bionema.com, using the subject line “Regulatory Affairs Specialist – Dr Minshad Ansari.”
Applications will be reviewed as they are received.
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