Senior Regulatory Affairs Specialist

Amicus Search & Recruitment; Manchester; Hybrid; GBP 100,000 - 125,000; Full time

Job summary

A dynamic recruitment firm is seeking a Regulatory Affairs Executive to drive regulatory compliance and product development in the crop protection industry. The role involves managing Article 34 and Article 43 projects, preparing technical dossiers, and ensuring compliance with EU regulations. Ideal candidates will have a BSc in a relevant field and experience in regulatory affairs. Flexibility for remote work is offered along with a competitive salary and career development opportunities.

Benefits

Competitive salary

Flexible remote or hybrid work options

Opportunities for career growth

Qualifications

• Minimum of a Bachelor of Science (BSc) degree in a relevant field.
• Experience in regulatory affairs within a relevant industry.
• Strong knowledge of EU regulatory frameworks and Article 34 of EU Regulation 1107/2009.

Responsibilities

• Drive applications for Article 34 and 43 projects.
• Manage product trials directly or through partners.
• Prepare technical dossiers and ensure project compliance.

Skills

EU regulatory frameworks

Project management

Technical dossier preparation

Organisational skills

Written and spoken English

Education

Bachelor of Science (BSc) in Life Sciences, Science, or Agronomy

Job description

🔬 Join a Dynamic Regulatory Team in the Crop Protection Industry!

The Client :

For over thirty years, our client, an Irish-owned family firm, has been a trusted supplier of plant protection products. They are keen on making sure their customers have a good experience all round, building proper long-lasting relationships, and keeping them coming back for more through good old-fashioned loyalty. At the heart of what they do, you'll find integrity, respect, honesty, and accountability.

They are quite flexible, offering remote or hybrid options depending on where you're based in Ireland, the UK, or across Europe.

The Opportunity :

As a Regulatory Affairs Executive, you will step into a pivotal, hands-on role at the intersection of regulatory compliance and product development. You will be instrumental in driving the company's growth through an exciting pipeline of projects, with a focus on Article 34 and Article 43 applications.

• Article 34 Projects : Drive a significant volume of applications for extra uses / extensions (Art. 34), managing trials, and actively tweaking formulations in collaboration with form chemists to deliver enhanced solutions.
• Article 43 Projects : Oversee the renewal of existing products (Art. 43), ensuring timely re-authorisation.
• Strategic Development : Take ownership of larger, more significant projects focused on formulation development. This includes preparing technical dossiers, identifying alternative formulants and raw materials, and moving products to the next stage of development.
• Project Management : Manage product trials directly or through strategic partnership with Contract Research Organisations (CROs) for specific parts of the project lifecycle.

What You'll Bring to the Table :

• A minimum of a Bachelor of Science (BSc) degree in a Life Sciences, Science, or Agronomy subject.
• Experience in regulatory affairs within a generic R&D company, consultancy, or CRO.
• A solid, practical grasp of EU regulatory frameworks, with demonstrable experience focusing on Article 34 of EU Regulation 1107 / 2009 for crop protection products.
• Proven ability to handle regulatory dossier preparation.
• Excellent written and spoken English, able to explain complicated technical information clearly and concisely.
• A can-do, solution-focused attitude with a real drive to get things done, particularly managing a high volume of projects.
• Great organisational skills and a keen eye for detail.

Bonus Points If You Have :

• Some knowledge of the crop protection industry, including the technical side, commercial bits, farming methods, and specific crop issues.
• Fluency in another major European language.

What's in it for You :

• A competitive salary that reflects your experience.
• The flexibility of working remotely or hybrid depending on your location (Ireland, UK, or Europe).
• The chance to work for a sound and growing Irish-owned company with a good reputation.
• A real opportunity to get involved in important technical and regulatory decisions and help shape our product strategy.
• A supportive and friendly team where your contributions are valued.
• Chances to grow and develop your career in the regulatory and formulation fields.

Contact Caitriona Breaw @ Amicus for more information.