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Regulatory affairs associate

Bray
Norbrook
Posted: 10 May
Offer description

Job Title: Veterinary Medicinal Products Regulatory Affairs Specialist
Job Summary:
We are seeking a highly motivated and experienced Veterinary Medicinal Products Regulatory Affairs Specialist to join our team at Norbrook. The successful candidate will be responsible for assisting in the registration and maintenance of Veterinary Medicinal Products worldwide.
Key Responsibilities:
* Compile regulatory applications for submission to Authorities and third-party Customers worldwide.
* Submit new product applications and provide support during the assessment and approval processes.
* Maintain and update existing authorisations.
* Respond to external queries from regulatory authorities and customers within strict deadlines.
* Work closely with all departments within Norbrook, providing regulatory support for the operations and control of the facility.
* Analyse scientific data and present the information in an organised format.
* Work closely with Customers to ensure all issues are addressed in an efficient and accurate manner.
* Perform 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.
* 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:
* At least 2 years' experience in the pharmaceutical industry or demonstrate relevant experience.
* Technical file and documentation experience.
* Project Management skills.
If you have a passion for regulatory affairs and a drive to succeed, we would love to hear from you.
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.

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