Regulatory Affairs Specialist

Are you an experienced Regulatory Affairs professional with a passion for biological cropprotection and sustainable agriculture? Do you enjoy navigating complex regulatory
landscapes while collaborating with international stakeholders? Then this opportunity asRegional Regulatory Affairs Specialist Northern Europe at Koppert could be your next
career step.
Regulatory Affairs Specialist - Northern EuropeFull-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?AsAs a Regulatory Affairs Specialist, you are responsible for securing and maintainingmarket access for Koppert's biological solutions across Northern Europe. You combineregulatory expertise with portfolio ownership and act as the connecting link betweencountry teams, commercial stakeholders and Global Regulatory Affairs.You will develop regulatory strategies, manage product registrations and provide expertadvice to support business growth and ensure compliance with regulatory requirements.Your responsibilities include:Managing an assigned part of the Northern European product portfolio, including newregistrations, renewals, extensions and maintenance activities
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Developing practical regulatory strategies that support business objectives and marketaccess
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Preparing, coordinating, reviewing and submitting regulatory dossiers, applications andresponses to competent authorities
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Acting as the primary regulatory contact for country organisations across NorthernEurope
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Managing regulatory timelines, registration commitments, data requirements andportfolio risks
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Providing regulatory guidance on product positioning, claims, conditions of use andmarket access opportunities
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Working closely with Product Management, Market Development, Product Pipeline, R&Dand Commercial teams
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Supporting launch planning and early-stage project assessments from a regulatoryperspecti...