Senior Regulatory Affairs Specialist
This role plays a pivotal part in driving company growth through an exciting pipeline of projects, focusing on Article 34 and Article 43 applications.
Key Responsibilities:
* The Senior Regulatory Affairs Specialist will drive a significant volume of applications for extra uses/extensions (Art. 34), managing trials, and collaborating with form chemists to deliver enhanced solutions.
* They will oversee the renewal of existing products (Art. 43), ensuring timely re-authorisation.
* Taking ownership of larger, more significant projects focused on formulation development, including preparing technical dossiers, identifying alternative formulants and raw materials, and progressing products to the next stage of development.
* Managing product trials directly or through strategic partnerships with Contract Research Organisations (CROs) for specific parts of the project lifecycle.
Requirements:
* 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 understanding 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 proactive, solution-focused attitude with a real drive to achieve results, particularly managing a high volume of projects.
* GREAT organisational skills and a keen eye for detail.