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The role of Regulatory Operations Specialist at Eurofins involves working as a key member of the EU Product Registration Team within the Crop Protection Regulatory Operations sector. This position focuses on managing crop protection product registration dossiers under EU Regulation 1107/2009. As part of this team, responsibilities include ensuring the compliance of regulatory dossiers with client quality standards and EU regulations, as well as acting as a liaison for regulatory requirements.
Collaboration with the Europe Regulatory Manager and various project teams to obtain and maintain authorizations for crop protection products across EU Member States.
Representation of regulatory and safety considerations within project teams, facilitating informed business decisions.
Management of relationships with internal and external stakeholders, including regulatory authorities and cross-functional teams.
Leadership in planning, submission, and post-submission activities focusing on new formulations and product renewals.
Development of project plans to ensure that regulatory submissions meet quality requirements and deadlines.
Contribution to the improvement of regulatory processes and initiation of efficient working methods.
Mentorship of junior team members, sharing knowledge and insights as the role matures.
Candidates interested in this position should possess several core competencies and experiences:
Professional Experience: A minimum of 5 years of experience in regulatory affairs or a closely related field is required. Familiarity with EU crop protection regulations and dossier requirements is also essential.
Educational Background: A Bachelor’s degree (BA/BS) or higher in a scientific discipline, IT, or business is necessary, with a preference for a PhD in relevant fields.
Knowledge and Skills: Strong scientific knowledge related to regulatory work is vital, alongside project management, problem-solving abilities, and excellent communication skills. Candidates must also demonstrate a proactive approach to anticipating and managing regulatory issues.
Language Proficiency: Fluency in English for technical discussions is mandatory. Knowledge of an additional major European language would be advantageous.
Other Competencies: The ability to work under tight timelines and a process-driven approach with strong critical thinking skills are also essential attributes.
At Eurofins, the company culture is built upon four key values: Teamwork, Integrity, Superlative Customer Satisfaction, and Productivity. They focus on creating a collaborative environment that encourages every team member to contribute their unique skills and perspectives. The commitment to integrity showcases their dedication to ethical practices, while aiming for superlative customer satisfaction emphasizes their goal of exceeding client expectations.
In terms of professional development, Eurofins is committed to providing substantial growth opportunities. Employees will have access to learning and development programs and mentorship, along with chances to engage in challenging projects that foster their career aspirations.
While the specific salary range for the Regulatory Operations Specialist is not explicitly mentioned in the job description, positions in regulatory affairs generally reflect competitive compensation packages depending on the candidate's experience and the specific demands of the role.
The position of Regulatory Operations Specialist within Eurofins offers an exciting opportunity for qualified candidates passionate about regulatory compliance in the agricultural sector. The job emphasizes teamwork, offers numerous opportunities for professional growth, and reflects a commitment to supporting safe agricultural practices. Candidates interested in applying for this role should ensure they meet the required qualifications and are prepared for the responsibilities outlined above.
This job offer was originally published on himalayas.app
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