Regulatory Affairs Specialist – Agri/Plant Protection
Regulatory Affairs Specialist – Agri/Plant Protection
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Senior Recruitment Consultant at Methodius Ltd. david@methodius.com
Excellent opportunity for an experienced Regulatory Affairs Officer to join a growing and expanding business in Oranmore, Co. Galway. My client provides a range of Gardening, Agricultural and Veterinary products for the Irish, UK and EU markets. The company is expanding both its product range and export potential. To achieve this, they are offering an exciting position as Regulatory Affairs Officer. Reporting to the Technical Director, the position will involve assisting in the preparation of dossier registrations as well as researching and implementing all the regulatory and registration requirements for their NPD pipeline. This is an exciting opportunity, offering diversity of work within regulatory affairs aspects of Plant Protection, Biocides and Biopesticide products.
KEY RESPONSIBILITIES:
The functions of the Regulatory Affairs Officer include but are not limited to the following;
* Assisting in the preparation of dossiers for submission to regulatory authorities across EU and Non EU countries.
* Preparation of study protocols, tendering of same, execution and receipt of final reports for trial work.
* Co-ordinating with Contract Research Organisations to ensure contracted work is being carried out to the required specification and within budget.
* 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 the generation of dossiers, 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.
COMPETENCIES AND EXPERIENCE:
* Qualification in a Scientific field, preferably in the life sciences / agricultural area.
* Knowledge of Regulation (EU) No 1107/2009, 528/2012, 2019/1009 and dossier build requirements would be advantageous.
* Organisational, personal efficiency, time management and the ability to prioritize competing demands are key skill requirements.
* 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.
Attitude and Personality:
* The ideal candidate will have a positive “can do” attitude with a willingness to win.
* Have the ability to work on own initiative and also work as part of a team.
This is a permanent role based in Oranmore, Co. Galway. Flexible working hours available.
The remuneration package on offer will reflect the importance of the role and the experience of the successful candidate. Benefits include, Bonus10%, laptop, phone, pension 5%, 20 weeks maternity/paternity leave, Bike to work scheme, end of year gift voucher, training scheme, training and developing fund, social club and others.
Candidates Must be eligible to work in the EU/Ireland,
We have exclusivity with this client. All applications will be dealt with in strict confidence.
Please do not hesitate to Contact David Coyle at 01 6351748 or email david@methodius.com
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Manufacturing, Production, and Research
* Industries
Agricultural Chemical Manufacturing, Chemical Manufacturing, and Environmental Services
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