Regulatory Affairs Specialist - Northern Europe

Are you an experienced Regulatory Affairs professional with a passion for biological crop protection and sustainable agriculture? Do you enjoy navigating complex regulatory landscapes while collaborating with international stakeholders? Then this opportunity as Regional Regulatory Affairs Specialist Northern Europe at Koppert could be your next career step.

Full-Time, 40 hours per week, Berkel en Rodenrijs (near Rotterdam)
This role follows a hybrid working model.

What will you do as Regulatory Affairs Specialist?
As a Regulatory Affairs Specialist, you are responsible for securing and maintaining market access for Koppert's biological solutions across Northern Europe. You combine regulatory expertise with portfolio ownership and act as the connecting link between country teams, commercial stakeholders and Global Regulatory Affairs.

You will develop regulatory strategies, manage product registrations and provide expert advice to support business growth and ensure compliance with regulatory requirements.

Your responsibilities include:

• Managing an assigned part of the Northern European product portfolio, including new registrations, renewals, extensions and maintenance activities
• Developing practical regulatory strategies that support business objectives and market access
• Preparing, coordinating, reviewing and submitting regulatory dossiers, applications and responses to competent authorities
• Acting as the primary regulatory contact for country organisations across Northern Europe
• Managing regulatory timelines, registration commitments, data requirements and portfolio risks
• Providing regulatory guidance on product positioning, claims, conditions of use and market access opportunities
• Working closely with Product Management, Market Development, Product Pipeline, R&D and Commercial teams
• Supporting launch planning and early-stage project assessments from a regulatory perspective
• Ensuring labels, Safety Data Sheets and product information remain compliant with national regulatory requirements
• Building and maintaining relationships with competent authorities, consultants and industry associations
• Monitoring changes in European and national legislation and translating them into clear actions and recommendations
• Representing Koppert in industry forums and contributing to discussions that support the future of biological solutions
• Identifying opportunities to improve regulatory processes, documentation and ways of working

A typical day as Regulatory Affairs Specialist
Your day may start with a question from a country team regarding an authorised product use or an upcoming product launch. You assess the regulatory implications, advise stakeholders and determine the best way forward.

Later in the day, you may review a registration dossier, coordinate input from technical experts, respond to authority questions or meet with Product Management to discuss regulatory risks and opportunities for new products. Throughout the day, you work closely with colleagues across multiple countries while ensuring projects remain on track and compliant with regulatory requirements.

What does the department/team look like?
You will be part of Koppert's Global Regulatory Affairs team and work closely with regulatory specialists covering different (scientific) disciplines, products and regions.

For Northern Europe, you act as the bridge between Global Regulatory Affairs and local country organisations. You will collaborate with stakeholders including:

• Country Regulatory Specialists
• Regional and Country Management
• Global and Regional Product Management
• Market Development teams
• Product Pipeline teams
• Research & Development (R&D)
• Project Management teams

The team combines scientific expertise with a pragmatic and collaborative mindset. You will have a high degree of ownership over your portfolio while benefiting from the support and knowledge of colleagues across the global organisation.

Who are you?
To be successful as a Regulatory Affairs Specialist, you bring:

• A Master's degree or equivalent in Biology, Microbiology, Biochemistry, Agriculture, Environmental Sciences, Regulatory Science or another relevant life-science discipline
• At least 3 years of experience in Regulatory Affairs or a related field
• Experience with plant protection products, biological solutions, regulatory authorities or regulatory consultancy
• Experience preparing, coordinating or reviewing regulatory submissions and authority responses
• Strong analytical skills and the…