Regulatory Affairs Officer - new opportunity

Regulatory Affairs Officer – a new opportunity with my client based in West Dublin.   

They 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. 
 
Key Responsibilities
•    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, CRO’s 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

Qualifications
•    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 tdunne@thornshaw.com