We have a fabulous opportunity for an accurate and performance driven Spanish speaking Regulatory Affairs Executive, with experience in the Agricultural or Agrochemical sectors, to join a fast-growing, international company in their Dublin office.
The Regulatory Affairs team is responsible for obtaining and maintaining product registrations for the company’s products, based on exacting regulatory requirements across international markets. You will be liaising with regulatory bodies in particular countries to ensure you understand what is required in order to compile dossiers for products to comply with each country’s legal standards.
You, in a nutshell: Suitable candidates will need to have an excellent academic record in a life sciences discipline, including a degree ideally agrochemical/chemistry based.
You will also need to possess demonstrable experience in a regulatory affairs role preferably within an industrial setting.
The ability to present clear and concise written arguments to support a specific regulatory or scientific position on a topic is fundamental to the role.
Languages: We are looking for fluent Spanish or Portuguese (written and oral) together with fluent English.
If you are a native Spanish or Portuguese speaker you will need to have fluent spoken English and good English writing skills; if you are a native English speaker you will need to be fluent in both written and spoken Spanish / Portuguese.
Opportunity: This is a technically demanding but very rewarding role for someone who is looking for the perfect opportunity to utilise their academics and experience in a growing, cutting-edge environment.
Key responsibilities as the Regulatory Affairs Executive will include:
* Preparing, reviewing and approving regulatory submissions for new product applications
* Maintaining existing authorisations across a number of countries
* Liaising with regulatory authorities, external consultants, CROs, test facilities and other internal departments in support of product authorisations
* Working with other regulatory teams to determine approval pathways to new markets
* Acting as a regulatory affairs representative on cross-functional project teams
* Preparing and reviewing guidance notes
* Confidential management of sensitive and technical information and collating and communicating data to team members
* Plus more.
What we’re looking for:
* Excellent academic record in a life sciences discipline including a degree - preferably agrochemical / chemistry based
* Fluent English and Spanish / Portuguese language skills
* Previous experience (2-3 years+) in regulatory affairs, ideally within an industrial setting
* Ability to present clear and concise written arguments to support a specific regulatory or scientific position on a topic
* Ability to perform tasks in an accurate and timely manner
* Excellent attention to detail
* Highly organised self-starter
* IT literate including MS Offie
* Ability to work calmly when under pressure and juggle demands
* Proactive team player
If you have the academics, experience and language skills we’re looking for then we want to hear from you ASAP!
Please ensure your CV showcases you fully and submit it now, quoting ‘LO- Spanish Regulatory Affairs Executive