Regulatory Affairs Officer – Compliance/Maintenance

Location UK / Ulster

Job Type Permanent full-time, TemporaryContract

Salary See description

Updated 2 days ago

Reference 1365218

 Job Description

To provide regulatory support in relation to defined dosage forms for all global regions with specific responsibilities for delivery of the compliance and maintenance of the Norbrook Veterinary Medicinal Products worldwide.

In Norbrook we pride ourselves in being one of the top 11 companies in Northern Ireland and in the top 15 veterinary pharmaceutical companies globally. We develop & manufacture veterinary medicines, supplying products to 120 countries globally. With a strong portfolio of existing products and significant investment in R&D to launch new products annually, we have opportunities for individuals to join us and develop their career in a global company.

Our business strategy is supported by our Values – Customer Value, One Team, Results Driven, Excellence, Innovation, and Quality – and we support our employees to live the behaviours that creates our culture.  Our on-going success is based on the expertise, knowledge and innovation of our employees. If you are interested in joining our team here at Norbrook and supporting our vision, then apply for this role.

 

Job Overview

To provide regulatory support in relation to defined dosage forms for all global regions with specific responsibilities for delivery of the compliance and maintenance of the Norbrook Veterinary Medicinal Products worldwide.

 

Main Activities/Tasks

  • Collation and recording of data and reports in readiness for the preparation of applications to regulatory authorities.
  • Maintenance and updating of existing authorisations.
  • Responding to external queries from regulatory authorities and customers within strict deadlines.
  • Working closely with all departments within Norbrook, providing regulatory support for the operations and control of the facility.
  • Analysing scientific data and presenting the information in an organised format.
  • Any other duties as deemed necessary by management

 

Essential Criteria:

  • Educated to a third level qualification or higher in Sciences, preferably a life science or at least 2 years’ experience in Regulatory Affairs.
  • Excellent organisational skills along with a proven ability to meet deadlines.
  • Meticulous approach, attention to details with a commercial insight and excellent communication and negotiation skills with the ability to work under his/her own initiative and as part of a dynamic regulatory affairs team.
  • Ability to analyse scientific data and present this information in an organised formatIT skills, particularly in relation to using databases

 

Desirable Criteria:

  • At least 2 years’ experience in the pharmaceutical industry or demonstrate relevant experience.
  • Basic knowledge of local, European and Global pharmaceutical regulations of medicinal products
  • Technical file and documentation experience
  • Project Management skills

 

Duration: Full Time, Permanent

Location: Newry, Co. Down

Remuneration: Salary Attractive

Benefits: Free Life Assurance, Paid Holidays, On-site Parking, Pension Scheme, Canteen Facilities, Healthcare plan, Childcare Vouchers, Discounted Car Insurance, Perks Scheme

Contact: The Human Resources Department

Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy we would particularly like to welcome applicants from the Protestant Community.