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Job Ref.: 1697

Job Title: Senior Regulatory Affairs Advisor (4 years plus experience) - Pharmaceuticals - Dublin - December 2018 - Urgent

Posted Date: 13/12/2018

Sector: Regulatory Affairs

Location: Ireland, Dublin

Job Type: Permanent full-time

Job description:

Senior Regulatory Affairs Advisor (4 years plus experience) - Pharmaceuticals - Dublin - December 2018 - Urgent

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

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

Role & Responsibilities:

  • Management of product complaints for products on the Irish market, from initial receipt through to closure, in conjunction with the company’s Global Complaints Department and in accordance with all relevant HPRA Guidelines, Regulations and Standard Operating Procedures.
  • Liaise with customers, in collaboration with the Sales/Marketing teams, regarding product quality issues and also in relation to medical/technical/clinical queries, ensuring an accurate and prompt response.
  • Provide annual training to all relevant personnel on the handling of complaints.
  • Support Pharmacovigilance, Medicovigilance and Compliance activities as directed when required.
  • Support our clients Global Regulatory Affairs with national regulatory information and advice as required.
  • Ensure all medicinal product registrations are current and marketed in full compliance with their approved registration files.
  • Provide input to the global regulatory affairs databases to ensure up-to-date status regarding national regulatory activities.
  • Preparation, submission and follow-up of medicinal product applications, as required and directed, to the HPRA and associated liaison with our clients Global Regulatory Affairs.

Skills & Experience Requirements:

  • A degree in a life science or pharmacy discipline.
  • Experience in Irish/European drug registration acivities
  • Knowledge of EU and national regulatory requirements.
  • Ability to process technical information.
  • Accuracy and excellent attention to detail.
  • Excellent organizational skills.
  • Strong verbal and written communication skills.
  • Good interpersonal skills.
  • Computer skills (Microsoft Word, Excel; SAP an advantage)

Candidates should ideally have 4+ years Regulatory experience in the pharmaceutical industry.

An excellent salary circa 60-65k 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


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