Connecting...

Senior Regulatory Officer

A leading pharmaceutical company are looking for a new Senior Regulatory Compliance Officer to join their growing team in Dublin.

You will be joining a diverse team who handle a variety of products in a fast pace environment. This is a great opportunity to develop your career as you will have immense exposure to a variety of different products and different markets within the pharmaceutical industry.

Essential Duties & Responsibilities:

  • Lead project teams or working groups as directed by management
  • Representing RA Compliance at relevant meetings / telecons / WebExs
  • Proactive identification and reporting of potential issues to management
  • Ongoing process and systems assessment to enable continuous development
  • Develop / deliver training as appropriate
  • Contribute to the development and implementation of RA policies, processes, SOPs and other
  • Perform assigned work according to good regulatory practice and in compliance with current legislation and regulatory guidelines
  • Peer review of dossier documents for accuracy, completeness and compliance
  • Oversee dossier build timelines for any assigned team projects
  • Assist RO's with managing risks and evolving timelines, and with remediation of issues

Experience:

  • Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
  • Minimum 3 years' experience in a regulatory affairs environment of the pharmaceutical industry
  • Knowledge of EU and other regions current registration and dossier requirements
  • Knowledge and ability to source International registration requirement information
  • Experience with systems and tools specific for RA and pharmaceutical sector

Culture:

A very inclusive multicultural environment that is very fast-paced and has an outgoing and enthusiastic team.

If you think you fit the requirements and would be interested in discussing further, please reach out with an up to date CV.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales