Regulatory Affairs Specialist
vor 4 Wochen
Company Description Eurofins Scientific is an international life sciences company that offers customers from various industries a unique range of analytical services to make life and our environment safer, healthier and more sustainable. From the food you eat to the water you drink to the medicines you rely on, Eurofins works with the world's largest companies to ensure the products delivered are safe, theirs Ingredients are authentic and labeling is accurate. The company is a leading global provider of analytics for food, environmental, pharmaceutical and cosmetic products as well as contract research (CRO) services. Eurofins has more than 900 laboratories within its global network, employing over 62’000 staff. Eurofins Professional Scientific Service® (PSS) is a global insourcing solution for our customers. Together with the customer, we define a project for the required services that our Eurofins employees should provide. During the ongoing project, the responsibility for project management, the previously defined services and the deployment of our employees in this project lies with Eurofins PSS. Job Description As a member of the EU Product Registration Team within Europe Crop Protection Regulatory Operations, you will: - Support the management of crop protection product registration dossiers under EU Regulation 1107/2009. - Review regulatory dossiers to ensure compliance with client quality standards and EU requirements. - Act as a liaison to collect and manage registration requirements and contribute to business process development with regulatory experts across Europe. Key Responsibilities: - Work with the Europe Regulatory Manager and project teams to obtain and maintain EU Member State authorizations for crop protection products - Represent regulatory and safety positions in project teams and facilitate business decisions - Manage relationships with internal and external stakeholders, including regulatory authorities and cross-functional teams - Lead planning, submission, and post-submission activities for new formulations and product renewal programs - Develop project plans to ensure timely and quality delivery of regulatory submissions - Contribute expertise to improve regulatory processes and lead initiatives for efficient ways of working. - Share knowledge and mentor others as your experience grows - Coordinate and manage team members working remotely to ensure that productivity, quality, documentation, working hours, and excellence are managed to maximum efficiency - Developing, coaching, motivating and building team morale through effective team work - Ensure that the customer receives the best possible service by continually reviewing best practice with regard to commercial and quality issues and ensuring 100% ethical working standards - Communicate regularly with customer and Eurofins management to ensure information is shared effectively and actions are taken immediately Note: Initial projects will include mentoring support from a senior expert, with responsibilities expanding as experience is gained. Qualifications Experience: - Minimum 5 years in regulatory affairs or related fields - In-depth knowledge of EU crop protection regulations and dossier requirements - Experience with regulatory processes in the EU or its Member States - Ability to anticipate and manage regulatory issues proactively - Fluent in English for technical discussions and advocacy Education & Skills: - BA/BS or higher in a scientific, IT, or business discipline (PhD preferred) - Strong scientific background relevant to regulatory work - Excellent planning, project management, and problem-solving skills - Ability to deliver quality work under tight timelines - Critical thinking and process-driven approach - Strong communication and advocacy skills - Understanding of Good Agricultural Practices (GAP) and crop protection product use in the EU - Knowledge of another major European language is an advantage - Willingness to travel within EAME - Leadership skills Additional Information Company Culture At Eurofins PSS, our company culture is deeply rooted in our four core values: Teamwork, Integrity, Superlative Customer Satisfaction, and Productivity. We believe in fostering a collaborative environment where every team member is encouraged to contribute their unique expertise and ideas. Our commitment to integrity drives us to uphold the highest ethical standards in all our endeavors. We strive for superlative customer satisfaction by understanding and exceeding our clients' expectations. Embracing productivity, we continuously seek innovative ways to streamline processes and deliver exceptional results. Together, these values form the foundation of a supportive and empowering workplace, enabling us to achieve excellence in everything we do. Opportunities for Growth As part of our commitment to employee development, we offer abundant growth opportunities at Eurofins PSS. You'll have access to learning and development programs, coaching & mentorship, and the chance to take on challenging projects, empowering you to achieve your professional aspirations. Equal Opportunity Employer Statement At Eurofins PSS, we are dedicated to being an equal opportunity employer, embracing diversity, and cultivating an inclusive workplace where every individual's unique background and perspective are valued, respected, and celebrated. Please note that as per Eurofins policy, we do not accept unsolicited resumes from third-party recruiters unless such recruiters were engaged to provide candidates for a specified opening. Any employment agency, person or entity that submits an unsolicited resume does so with the understanding that Eurofins will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity.
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