Regulatory Affairs & Field Sciences Manager - Europe at Oath
Ireland
<p><strong>About Oath:</strong><br>Oath, a public benefit company, regenerates life in depleted soils globally with naturally occurring, beneficial microorganisms to address some of agriculture’s biggest challenges, including yield, nutrient density, and soil carbon. When you join Oath, you become part of a collaborative network that prioritizes conducting high-quality scientific research. You will have access to a team of highly trained scientists, study directors, and a wide network of collaborators, enabling you to integrate and enhance your existing skill set.</p> <p><strong>Position Summary:</strong><br>This role is a critical part of the Business Development team in Europe, reporting to the BD Lead Europe. The Regulatory Affairs & Field Sciences Manager Europe is responsible for achieving and maintaining regulatory Freedom To Operate (FTO) for Oath's 'Oath Soil Life' microbial soil amendments throughout Europe, as well as coordinating field trials implementation through several trialing partners across Europe.The field science focus is on ensuring the delivery of high quality trial results across a range of CROs and trialing partners, across the <strong>region. The regulatory focus is on leveraging EU member state legacy regulations and securing Mutual Recognitions across the region. The scope includes the European Union, the UK, Turkey, and the Middle East, to be addressed as required.</strong></p> <p><strong>Responsibilities:</strong></p> <p><strong><em>Regulatory (60%)</em></strong></p> <ul> <li style="font-weight: bold;"><strong>Develop and execute the regulatory strategy for Oath Soil Life in Europe, prioritizing the use of member state legacy processes and the Mutual Recognition (MR) directive to gain FTO</strong><br><strong>quickly and cost-effectively.</strong></li> <li style="font-weight: bold;"><strong>Manage all aspects of the product registration process, including preparation and submission of necessary documentation to regulatory bodies, such as applications for a</strong><br><strong>certificate of conformity in Austria (e.g., via § 9 DMG).</strong></li> <li style="font-weight: bold;"><strong>Oversee regulatory compliance for Oath Soil Life, ensuring strict adherence to all local, national, and international regulations across Europe, UK, Turkey, and the Middle East.</strong></li> <li style="font-weight: bold;"><strong>Serve as the primary liaison with regulatory agencies or coordinate with local contractors to efficiently secure approvals and maintain compliance.</strong></li> <li style="font-weight: bold;"><strong>Monitor changes in the European regulatory environment, including new regulations like EC 2019/1009, and update strategies to maintain a competitive advantage.</strong></li> <li style="font-weight: bold;"><strong>Document all regulatory submissions, official communications, and prepare detailed reports on the regulatory status and compliance efforts for internal and external</strong><br><strong>stakeholders.</strong></li> <li style="font-weight: bold;"><strong>Provide regulatory support for business development activities and market entry initiatives in the region, particularly for countries requiring local trialing/data such as Turkey.</strong></li> </ul> <p><strong><em>Field Sciences (40%)</em></strong></p> <ul> <li style="font-weight: bold;"><strong>Support the elaboration of the field and nursery trial programs across Europe (incl. UK) and Türkiye.</strong></li> <li style="font-weight: bold;"><strong>Oversee and track the execution of field and nursery trial programs to confirm the performance of Oath Soil Life across diverse ecological conditions.</strong></li> <li style="font-weight: bold;"><strong>Guarantee the timely submission of premium experimental data while providing technical oversight for trial quality assurance and control processes.</strong></li> </ul> <p><strong>Competencies:</strong></p> <ul> <li style="font-weight: bold;"><strong>In-depth knowledge of European and national regulatory frameworks for abiotic agricultural inputs, especially biostimulants, soil amendments, and microbial products.</strong></li> <li style="font-weight: bold;"><strong>Proven track record in managing product registration, dossier preparation, and achieving regulatory compliance for commercial products.</strong></li> <li style="font-weight: bold;"><strong>Demonstrated expertise in the conceptualization, planning, and operational execution of regional trial programs.</strong></li> <li style="font-weight: bold;"><strong>Exceptional ability to establish project timelines and manage complex regulatory and field sciences milestones.</strong></li> <li style="font-weight: bold;"><strong>Strong verbal and written communication skills for discussions with regulatory bodies, CROs and managing internal/external stakeholder relationships.</strong></li> <li style="font-weight: bold;"><strong>Ability to work effectively within a high-performing Business Development and cross-functional team.</strong></li> </ul> <p><strong>Qualifications:</strong></p> <ul> <li style="font-weight: bold;"><strong>Minimum 5-7 years of relevant experience in Regulatory Affairs within the agricultural sector.</strong></li> <li style="font-weight: bold;"><strong>Demonstrated experience in European regulatory affairs, particularly using EU Mutual Recognition and legacy national abiotic registration processes.</strong></li> <li style="font-weight: bold;"><strong>Comprehensive grasp of the scientific protocols and prerequisites for field-based research.</strong></li> <li style="font-weight: bold;"><strong>Field trial experience highly desirable</strong></li> <li style="font-weight: bold;"><strong>Degree in Agronomy or a related field</strong></li> </ul> <p><strong>Location:</strong></p> <ul> <li>Remote, preferably from Ireland or Spain, Italy, Germany</li> <li>80-100%</li> </ul>
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