We are seeking an experienced and strategic Regulatory Affairs Project Lead to join our Regulatory Affairs team. This is a key role responsible for preparing and submitting regulatory applications across major EU markets, while leading regulatory workstreams for both new product development and renewal of existing product authorisations.
This is a unique opportunity to join a collaborative and forward-thinking team where your contributions will directly influence regulatory strategy and decision-making across the organisation.

Qualifications & Experience

• Minimum BSc in Life Sciences, Agronomy, Chemistry, or a related scientific field.
• At least 7 years of Regulatory Affairs experience within a generic R&D company, consultancy, or CRO.
• Proven experience with EU regulatory submissions is essential.
• Familiarity with the crop protection industry (technical, commercial, or agricultural practices) is desirable.
• Strong understanding of Regulation (EC) No 1107/2009 and its key articles (33, 34, 40, 43

Key Skills & Competencies

• Excellent project management and multitasking skills.
• Strong verbal and written communication abilities.
• Proven ability to build and maintain effective professional relationships with internal teams and external stakeholders.
• Proactive, solution-oriented, and able to anticipate regulatory risks and challenges.
• High attention to detail with excellent organisational and time management skills.
• A collaborative team player who can also work independently when needed.
• Fluency in English is essential; fluency in another major European language is highly desirable

Project Management

• Prepare and project manage registration dossiers under Regulation (EC) No 1107/2009, including:
• Applications for generic authorisation under Articles 33/34
• Renewals under Article 43
• Mutual Recognition procedures under Article 40
• Act as Project Leader for designated Generic New Product Development projects.
• Represent the company on relevant Task Forces.
• Monitor progress of all regulatory submissions, respond to authority queries promptly, and ensure that regulatory requirements are met in a planned and timely manner to avoid delays in approvals.
• Commission studies with Contract Research Organisations (CROs) and monitor their progress to ensure target timelines are met.
• Manage multiple projects simultaneously, including both internal projects and outsourced projects managed via consultants.

Regulatory Strategy

• Actively contribute to the development of regulatory strategies, supporting both short-term and long-term business goals.
• Stay up-to-date with EU and national regulatory guidelines and industry developments to inform regulatory approaches and decisions.

Relationship Management

• Build and maintain strong, collaborative relationships with:
• Regulatory Authorities
• Consultants and CROs
• Internal departments including R&D, Commercial, and Operations teams

Quality & Compliance

• Ensure the submission of high-quality regulatory applications.
• Engage with Regulatory Authorities prior to submission to discuss data requirements and ensure a right-first-time approach.
• Provide a professional, courteous, and solution-focused regulatory service to both internal and external stakeholders.

Additional Responsibilities

• Monitor regulatory developments and assess their impact on ongoing and future projects.
• Provide internal expert guidance on regulatory requirements and timelines to cross-functional teams.
• Contribute to other duties as required, in line with the company’s policy of flexibility and cross-functional support.

Qualifications & Experience

• Minimum BSc in Life Sciences, Agronomy, Chemistry, or a related scientific field.
• At least 7 years of Regulatory Affairs experience within a generic R&D company, consultancy, or CRO.
• Proven experience with EU regulatory submissions is essential.
• Familiarity with the crop protection industry (technical, commercial, or agricultural practices) is desirable.
• Strong understanding of Regulation (EC) No 1107/2009 and its key articles (33, 34, 40, 43)

Key Skills & Competencies

• Excellent project management and multitasking skills.
• Strong verbal and written communication abilities.
• Proven ability to build and maintain effective professional relationships with internal teams and external stakeholders.
• Proactive, solution-oriented, and able to anticipate regulatory risks and challenges.
• High attention to detail with excellent organisational and time management skills.
• A collaborative team player who can also work independently when needed.
• Fluency in English is essential; fluency in another major European language is highly desirable.

What We Offer

• A strategic and impactful role with direct influence on regulatory outcomes.
• A supportive and collaborative team environment focused on professional growth.
• Involvement in shaping regulatory strategy across multiple European markets.
• Cross-functional exposure with international teams and regulatory bodies.
• Opportunities for career development and continuous learning within a dynamic and growing organisation.