Role Details
Role Title: Regulatory Affairs Officer - Veterinary
Reporting To: Head of Technical, Regulatory & Quality
Location: Oranmore, Co. Galway
Type: Full-time, 1 Year Fixed Term
Role Purpose
The Regulatory Affairs Officer - Veterinary is responsible for the preparation and submission of all regulatory dossiers to support Hygeia’s veterinary portfolio.
This is an exciting opportunity to work with veterinary regulatory dossiers, as well as some cross functional opportunities to work with Plant Protection, Biocides and Biopesticide dossiers.
Key Responsibilities
The functions of the Regulatory Affairs Officer include but are not limited to the following:
Preparation of veterinary dossiers for submission to regulatory authorities.
Preparation and submission of variation applications for existing MA’s
Preparation of study protocols and reports for eco-tox, residue and efficacy studies
Deliver high quality work to agreed timelines in order to effectively meet submission milestones.
Critically analyse complex data and condense into clear and attainable action points.
Maintain knowledge and awareness of emerging regulations/guidelines.
Problem solving: propose and evaluate solutions to regulatory issues; prepare contingency plans
Timely and accurate preparation of dossiers for submission and response to authority questions
Attention to detail in generation of dossier, protocols and reports
Ability to work on multiple projects simultaneously
Support all regulatory aspects of assigned projects associated with business objectives.
Provide regulatory guidance in relation to new product development when needed. Prepare requests for scientific advice.
Cross functional ability to work with Plant Protection, Biocides and Biopesticide dossiers.
Competencies:
Knowledge of VICH guidelines and dossier build requirements.
Organisational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.
Ability to build relationships and collaborate with others.
Positive self-starter who has the ability to review complex task and the ability to communicate proposed action to management.
Strong computer skill
Application Process:
Apply via our job's portal with a cover letter and up to date CV. The closing date for applications is Tuesday, 8th of September at 11am.
Hygeia is an equal opportunities employer