On behalf of my client, we are seeking candidates for a new Regulatory Affairs Officer opportunity. Permanent role based in West Dublin.
We are looking for a team player who also has a strong ability to project manage and navigate the complex EU regulatory system in an independent manner. Someone with a dynamic attitude to work, pro-active in problem solving and decision making.
A person with 2 + years experience in the Agrochemical Regulatory Industry with a knowledge of a variety of application submissions across the EU.
To prepare and project manage high quality registration dossiers for approval by Regulatory Authorities in Europe
To monitor the progress of New Product Development, Renewal and Re-Authorisation submissions, respond to queries as they arise and ensure that regulatory requirements are met in a planned and timely manner to avoid delays in approval
Commission studies with Contract Research Organisations and monitor the progress of the studies to ensure the target dates are maintained
Contribute towards the development of the Regulatory Strategy
Keep up to-date with national and EU regulatory guidelines
Build and maintain strong relationships with Regulatory Authorities, Consultants, CROs and internal departments
Comply with the Lean Principles being embedded throughout the Organisation
Participate in Continuous Improvement Initiatives to further develop department functions.
Work closely with the Sales and Commercial Teams to deliver viable products to the market
A Bachelors degree, in Science or a related discipline
Competencies & Experience required
2+ years experience in European Regulatory Affairs
Strong analytical and associated problem solving ability
Excellent Communication skills
Good time management and strong on attention to detail
Effective decision making
Able to work under supervision or on own
Knowledge and proficient in the use of Microsoft Word, Excel etc.
Detailed understanding of IT Systems and Database Administration desirable
For further detail contact Tina +353 1 2784671 or email your CV to email@example.com