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Job Ref.: 1682

Job Title: Regulatory Affairs Executive - Pharmaceuticals - Dublin West - October 2018 - Urgent

Posted Date: 18/10/2018

Sector: Regulatory Affairs

Location: Ireland, Dublin West

Job Type: Permanent full-time

Job description:

Regulatory Affairs Executive - Pharmaceuticals - Dublin West - October 2018 - Urgent

Our client, a major pharma company based in Dublin West currently have a vacancy for an experienced Regulatory Affairs Executive to work within their Regulatory Affairs Department.

This is a permanent full time position. The position will report into the Head of Regulatory Affairs.

Responsibilities:

  • Management of the product authorisations of assigned national products, and national regulatory aspects of assigned centralised products.
  • Communication of changes to product licences and the distribution of updated SmPCs to the relevant company personnel.
  • Responsible for the information flow from the Global Regulatory Group to relevant colleagues ensuring that the relevant individuals are fully up to date with the regulatory status of our clients’ products.
  • Responsible for the publication of SmPCs for assigned products and the updating/maintenance of associated artwork.
  • Responsible for the preparation of Abridged Prescribing Information for promoted products and regulatory review of promotional materials.
  • Preparation of Dear Healthcare Professional Communications (DHPCs) and ensuring the timely printing and distribution of these.
  • Responsible for the regulatory maintenance of assigned clinical trials.
  • Involvement in the product recalls process as required.
  • Involvement in the compassionate use process from a regulatory perspective as required.
  • Responsible for informing the HPRA or EU Programme Manager (for centralised products) of temporary product shortages or product discontinuations
  • Represent the regulatory function in cross-functional teams /task forces to support the business.

Key Skills requirements:

  • BSc (life sciences/health sciences degree) OR clear demonstration of scientific knowledge/aptitude
  • A min of 2-3 years’ experience in regulatory affairs, particularly in the area of product licence management
  • Good understanding of core processes; discovery, development, manufacturing and marketing.
  • Demonstrates leadership, proactivity and department level approach to work, thinking beyond immediate responsibilities and applying knowledge to situations outside the scope of their projects.
  • Commitment to performance measures of time, costs and quality
  • Excellent attention to detail and accuracy.

An excellent salary plus bonus and benefits package will be offered to the successful candidate

For further information, please contact Paul Flanagan at Dublin (01) 805 5522 or e mail your c/v in the strictest confidence to paul@pharmasolutions.ie

 

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