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Contact Info
Libby O'Donoghue
Life Science

+353 1 507 9254
[email protected]
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Westmeath
QA Specialist
Limerick
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Details

Regulatory Affairs Specialist (LOA007553)


Reference:A007553 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Specialist, Regulatory Affairs

Our competitive advantage is based on being first to market. Due to ongoing growth of our product portfolio and entry into new markets, we have exciting opportunities in our Regulatory Affairs team for scientists who wish to put their knowledge and training to use in a fast-paced, results-focused commercial R&D environment.

The Regulatory Affairs team are responsible for obtaining and maintaining product registrations, based on exacting regulatory requirements. Currently working across EU markets, success comes in the form of achieving and retaining the authorisation of products, through a variety of documentation.

These roles will be a fundamental part of our R&D team, and the successful candidates will be responsible for key deliverables, fundamental to the company’s long-term strategies in European and global markets. Core to our success is recruiting the right people who will thrive in our culture, enabling company performance to excel while also achieving their personal career goals.
Strong communication and organisational skills are key, as well as attention to detail and the focus to get the job done in an efficient, timely and accurate manner. This is a technically demanding, but very rewarding role for scientists looking to forge a career in a cutting-edge crop protection company.


If you are looking for the opportunity to use your expertise and knowledge every day to make a difference, come join us.

Main Responsibilities will include:

  • Preparation, review and approval of regulatory submissions for new product applications

  • Maintenance of existing authorisations across a number of countries

  • Liaise with regulatory authorities, external consultants, CROs, test facilities and other internal departments (e.g. laboratory) in support of product authorisations

  • Work with other regulatory teams to determine approval pathways to new markets

  • Regulatory affairs representative on cross-functional project teams

  • Preparation and review of guidance documents

  • Confidential management of sensitive and technical information, along with collating and communicating data to team members

  • Any other tasks deemed appropriate by Regulatory Affairs Manager

Attributes:



  • Excellent academic record in a life sciences discipline, e.g. BSc (mandatory), preferably agrochemical/chemistry based, minimum 2.1

  • Minimum of 2-3 years’ experience in regulatory affairs, ideally within a crop protection industrial setting

  • Ability to present clear and concise written arguments to support a specific regulatory or scientific position on a topic

  • Perform tasks in an accurate, timely and efficient manner

  • Excellent attention to detail is a must

  • Ability to work on own initiative or as part of a team, in meeting strict timelines

  • Excellent organisational skills with the ability to multi-task and work in an environment with shifting priorities

  • Proactively seek to add value to processes, both existing and new

  • Performance driven, with a 'can-do' attitude

  • Proficiency in Microsoft Word, Excel, PowerPoint.

  • Proficiency in an EU language (French/German/Spanish/Italian) would be an advantage