Regulatory Affairs Associate

Job Overview

To assist in registration and maintenance of Veterinary Medicinal Products in the US and Canadian Markets

Main Activities/Tasks

• The compilation of regulatory applications for submission to the US FDA and Canadian Authorities and third-party Customers worldwide.
• Submission of new product applications and providing support during the review and approval processes.
• Maintenance and updating of existing product applications.
• Analysing scientific data and presenting the information in an organised format.
• Responding to external queries from regulatory authorities and customers within strict deadlines.
• Working closely with all departments within Norbrook, providing regulatory support for the operation and control of the facility.
• 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:

• 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.
• Ability to analyse scientific data and present this information in an organised format.
• Meticulous approach and attention to detail
• Excellent communication and negotiation skills verbally and in writing.
• Ability to work under his/her own initiative and as part of a dynamic worldwide regulatory affairs team.
• 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 US and Canadian pharmaceutical regulations of medicinal products.
• Prior experience in product development, formulations, analytical methods or drug product manufacturing
• 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.