Regulatory Affairs Officer

Website Ref: TPM04434

Summary:
A Regulatory Affairs Officer is required for a pharmaceutical company in South Dublin. The successful candidate will support the commercial regulatory affairs environment of our client’s Animal Health organisation in Ireland. The primary objective of the role is to obtain and maintain veterinary medicinal product marketing authorisations in line with business and legal requirements in the Republic of Ireland.

Responsibilities:

  • This role is responsible for undertaking a variety of regulatory activities for a range of veterinary medicinal products.
  • 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 (labelling text and packaging artwork) in line with regulatory requirements and company labelling 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 and GDP responsibilities may be part of this role.

Qualifications & Experience:

  • 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 a commercial regulatory environment would be considered an advantage and is preferred, but not essential.
  • Ability to assess quality of technical data in relation to regulatory requirements.
  • Ability to assemble and present data.
  • Excellent computer skills are essential.
  • Sound working knowledge of Microsoft Office 2010 applications and ability to work in/with a variety of customised applications.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.