法规事务与现场科学经理-欧洲
Regulatory Affairs & Field Sciences Manager - Europe
关于Oath：
Oath是一家公共利益公司，通过天然存在的有益微生物在全球退化土壤中再生生命，以解决农业的一些最大挑战，包括产量、营养密度和土壤碳含量。加入Oath，你将成为一个优先进行高质量科学研究的协作网络的一部分。你将有机会接触到一支受过高度培训的科学家团队、研究主管以及广泛的合作者网络，从而整合并提升你现有的技能。
职位概述：
该职位是欧洲业务发展团队中的关键角色，向欧洲业务发展负责人汇报。欧洲法规事务与田间科学经理负责在欧洲实现并保持Oath的“Oath Soil Life”微生物土壤改良剂的自由实施（FTO）权利，同时协调通过多个试验合作伙伴在欧洲开展的田间试验。田间科学的重点是确保在该地区各种CRO和试验合作伙伴处交付高质量的试验结果。法规方面则侧重于利用欧盟成员国的既有法规，并在该地区获得相互认可。该范围包括欧盟、英国、土耳其和中东地区，根据需要进行处理。
职责：
法规事务（60%）
- 制定并执行欧洲“Oath Soil Life”的法规策略，优先使用成员国既有流程和相互认可（MR）指令，快速且经济地获得FTO。
- 管理产品注册的所有方面，包括准备和向监管机构提交必要文件，例如奥地利符合性证书申请（如通过§ 9 DMG）。
- 监督“Oath Soil Life”的法规合规性，确保严格遵守欧洲、英国、土耳其和中东的所有本地、国家和国际法规。
- 作为与监管机构的主要联络人，或协调当地承包商，以高效地获得批准并保持合规。
- 监控欧洲监管环境的变化，包括新法规如EC 2019/1009，并更新策略以保持竞争优势。
- 记录所有法规提交内容、官方沟通，并为内部和外部准备详细的法规状态和合规工作报告。
查看英文原文
About Oath:
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.
Position Summary:
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 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.
Responsibilities:
Regulatory (60%)
- 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
- quickly and cost-effectively.
- Manage all aspects of the product registration process, including preparation and submission of necessary documentation to regulatory bodies, such as applications for a
- certificate of conformity in Austria (e.g., via § 9 DMG).
- 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.
- Serve as the primary liaison with regulatory agencies or coordinate with local contractors to efficiently secure approvals and maintain compliance.
- Monitor changes in the European regulatory environment, including new regulations like EC 2019/1009, and update strategies to maintain a competitive advantage.
- Document all regulatory submissions, official communications, and prepare detailed reports on the regulatory status and compliance efforts for internal and external
- stakeholders.
- Provide regulatory support for business development activities and market entry initiatives in the region, particularly for countries requiring local trialing/data such as Turkey.
Field Sciences (40%)
- Support the elaboration of the field and nursery trial programs across Europe (incl. UK) and Türkiye.
- Oversee and track the execution of field and nursery trial programs to confirm the performance of Oath Soil Life across diverse ecological conditions.
- Guarantee the timely submission of premium experimental data while providing technical oversight for trial quality assurance and control processes.
Competencies:
- In-depth knowledge of European and national regulatory frameworks for abiotic agricultural inputs, especially biostimulants, soil amendments, and microbial products.
- Proven track record in managing product registration, dossier preparation, and achieving regulatory compliance for commercial products.
- Demonstrated expertise in the conceptualization, planning, and operational execution of regional trial programs.
- Exceptional ability to establish project timelines and manage complex regulatory and field sciences milestones.
- Strong verbal and written communication skills for discussions with regulatory bodies, CROs and managing internal/external stakeholder relationships.
- Ability to work effectively within a high-performing Business Development and cross-functional team.
Qualifications:
- Minimum 5-7 years of relevant experience in Regulatory Affairs within the agricultural sector.
- Demonstrated experience in European regulatory affairs, particularly using EU Mutual Recognition and legacy national abiotic registration processes.
- Comprehensive grasp of the scientific protocols and prerequisites for field-based research.
- Field trial experience highly desirable
- Degree in Agronomy or a related field
Location:
- Remote, preferably from Ireland or Spain, Italy, Germany
- 80-100%
Originally posted on Himalayas