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Regulatory Affairs Specialist

Quality & Laboratory
Claire McGuckin
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Job Reference: JO-2004-65114_1586436185


This role is responsible for undertaking a variety of regulatory activities for a range of veterinary medicinal products including:

- Submission of new marketing authorisation applications, management and maintenance of existing marketing authorisations via submission of applications to vary marketing authorisations, submission of renewal applications, and other submissions to ensure regulatory and market compliance in Ireland.

- Generation, maintenance and control of product literature approvals (labeling text and packaging artwork) in line with regulatory requirements and company labeling artwork approval systems.

- Coordination of communication with global regulatory and European licensing team colleagues to ensure appropriate documentation is supplied to the regulatory authorities within appropriate timelines.

- Communication of marketing authorisation change approvals to ensure efficient and compliant change implementation.

- Provide internal advice and expertise on all regulatory matters in support of support of business objectives.

- Supporting and maintaining local company regulatory and quality compliance systems.

- Some GDPR responsibilities are part of this role

Qualifications, Skills & Experience Required

- A degree in a discipline that is relevant such as a life-sciences degree or suitable alternative such as veterinary science or pharmacy or related subject matter.

- Experience in regulatory affairs.

- Experience in a commercial regulatory environment would be considered an advantage and is preferred, but not essential.

- Excellent computer skills are essential. Sound working knowledge of Microsoft Office 2010 applications and ability to work in/with a variety of customised applications.

- Excellent verbal and written communication skills, with the ability to interact with a wide range of people both internal and external, including regulatory authorities.

- Meticulous approach and attention to detail.

- The ability to work to challenging deadlines and managing conflicting priorities.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Claire McGuckin
Claire McGuckin
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Quality & Laboratory
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