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Job Ref.: 1705

Job Title: Senior Regulatory Affairs Officer - Pharmaceuticals - Dublin - January 2019 - Urgent

Posted Date: 15/01/2019

Sector: Regulatory Affairs

Location: Ireland, Dublin

Job Type: Permanent full-time

Job description:

Career Opportunities - 2019

Senior Regulatory Affairs Officer - Pharmaceuticals - Dublin - January 2019 - Urgent

Our client, a major pharma company based in Dublin currently have a vacancy for an experienced Senior Regulatory Affairs Officer to play a leading part in their Medical Affairs Department.

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

MAIN DUTIES AND RESPONSABILITIES

Reporting to the Head of Regulatory Affairs, the Snr Regulatory Affairs Officer will:

  • Ensure the maintenance of regulatory authorisation for the new and existing products in compliance with local legislation and Marketing Company Code/SOP

  • Guarantee the maintenance and compliance to GRP and local SOPs

  • Ensure interaction with Regulatory Authorities through regular contact to improve and maintain company reputation and Regulatory Outcomes

MAIN ACCOUNTABILITIES

The role broadly includes the following key components:

  • Work closely with the Regulatory Head to manage the transfer of the Regulatory Portfolio and associated regulatory activities from the UK to Ireland.
  • Help establish the new Regulatory function in Ireland and implementation of new regulatory processes in close collaboration with the Regulatory Head

  • Prepare / submit National and MRP post marketing variations (renewals, quality and safety updates) to the RA for designated product portfolio

  • Lead and work collaboratively with EU Regulatory Team during registration application for new products, new indications, and extensions, in compliance with current national and EU legislation

  • Collaborate cross functionally (regulatory, quality, supply chain etc) to ensure the correct implementation of variations at a national level

  • Interact with the HPRA to solve any product, quality or regulatory related issues

  • Responsible for Good Regulatory Practice within Ireland as per Company’s Quality Management System

  • Manage Irish Regulatory Budget and provide the Irish business with relevant information on resource and fees

  • Keep the company abreast of regulatory trends, risks and opportunities for the business

  • Regulatory representative and oversight of internal investigations for local regulatory / quality in line with Company SOP

  • Act as local Product Recall Administrator and manage potential product recalls in Ireland

ESSENTIAL REQUIREMENTS

Education, Qualifications, Skills and Experience

  • Degree qualified in Life Sciences, pharmacy or related discipline

    SKILLS

  • Excellent knowledge of National, EU pharmaceutical legislation and the IPHA code

  • Excellent written and verbal communication skills

  • Problem solving

  • Time management and stress resilience/ emotional stability

  • Performance Driven

  • Customer focus

  • Influencing

    EXPERIENCE

  • 4-5 Years of experience as Regulatory Affairs Specialist within pharmaceutical companies;

  • Experience of working on cross-functional teams

    Desirable

  • Post graduate qualification in relevant discipline

  • Prior experience working for a Health Authority

  • Prior experience in a clinical / pharmacovigilance and / or Quality environment

  • Member of TOPRA

  • Line Management experience

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 paul@pharmasolutions.ie asap

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