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.
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