Job Category: QUALITY / R&D

Regulatory Affairs Project Lead – Chemical Crop Protection

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.

Key Responsibilities
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.

Why Choose Clark?

• Inclusive & Supportive: We welcome diversity, ensure equal opportunities, and provide reasonable accommodations for interviews.
• Expert Guidance: Our experienced recruiters are dedicated to finding the right fit for you.
• Personalised Support: We’re with you every step of the way to ensure a smooth job search.
• Ready to take the next step? Apply now.

INDCLA 

Regulatory Specialist – Chemical Crop Protection

Overview
Reporting to the Regulatory Affairs Manager, this strategic position involves preparing and submitting regulatory applications in key markets in the EU, acting as Project lead in support of the new product development programme and renewal of existing product authorisations. This strategic position will offer the right candidate the opportunity to work in a strong collaborative team environment, have significant involvement in decision-making and participate in the development of regulatory strategy.

The position requires strong communication skills in order to build and maintain strong relationships with Regulatory Authorities, consultants, contract research organisations (CRO’s) and to provide a respectful, professional service both internally and externally. Excellent project management and multitasking skills are a requirement to ensure that the company’s regulatory objectives are met in a planned and timely manner.
The ideal candidate will have a minimum of a BSc in a Life Sciences/Science/Agronomy subject, including significant experience (minimum 7+ years) and knowledge of regulatory affairs in a generic R&D Company, consultancy or CRO. Basic knowledge of the crop protection industry: technical, commercial, farming techniques, crop-specific issues, etc. is desirable but not essential.
English is essential, with fluency in one other major European language desirable.

Key skills:

• Project management and multitasking skills
• Strong communication skills
• Team player
• Solution focussed.
• Ability to build and maintain relationships
• Fluent knowledge of written and verbal English
• Highly organized and result-oriented.