Regulatory Affairs Specialist
2 settimane fa
Job Description This role offers the flexibility to work remotely from any of the following locations : several EU countries, the UK and Switzerland. 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 : 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.
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