Regulatory Affairs Associate

Job Overview

To assist in registration and maintenance of Veterinary Medicinal Products worldwide

Main Activities/Tasks

• The compilation of regulatory applications for submission to Authorities and third-party Customers worldwide.
• Submission of new product applications and providing support during the assessment and approval processes.
• 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.
• Work closely with Customers to ensure all issues are addressed in an efficient and accurate manner.
• Any other duties as deemed necessary by management.

Essential Criteria:

Applicants must therefore demonstrate the following essential criteria on their application form in order to be considered:

• Educated to a third level qualification or higher in Science, preferably a life science.
• Excellent organisational skills along with a proven ability to meet deadlines.
• Meticulous approach and attention to detail with a commercial insight and excellent communication and negotiation skills.
• 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 format.
• IT skills, particularly in relation to Powerpoint, Adobe and Excel.

Desirable Criteria:

Due to the nature of the role preference will be given to applicants demonstrating the following 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

Additional Information:

Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
We regret that applications received after the closing date and time will not be accepted

Benefits:

Free Life Assurance
Company Pension Scheme
Healthcare cash plan
32 days annual leave
Wedding Leave
Company Sick Pay
Employee well-being initiatives
Employee Assistance Programme
On-site free parking
Canteen Facilities
Employee Perks scheme
Employee Recognition scheme
Career development opportunities

Contact: recruitment@norbrook.co.uk

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.