Senior Regulatory Affairs Officer

Posted 18 December 2020
Job type Permanent
DisciplineLife Sciences & Engineering Technologies, Science Leaders & Specialists
ContactHelena Boyle

Job description

This leading pharmaceutical group has operations in South Dublin and the UK and are focussed on the development and commercialisation of speciality products and other high-value niche products. Due to growth, there is an opportunity for an experienced Senior Regulatory Affairs Officer to join the team.

The Role

Duties and responsibilities of the Senior RA Officer will include:

  • Review current registration dossier for all marketed products to identify and record dossier completeness, formatting issues, compliance with guidelines/legislation, on-going regulatory issues (pending variations) and outstanding regulatory commitments
  • Ensure timely preparation and compilation of registration dossier for assigned projects in accordance with EU and international standards
  • Managing and coordinating various regulatory activities throughout the life cycle of the project/product
  • Maintain assigned products' Marketing Authorisations via timely variations and renewals submissions and their approvals
  • Ensure meeting registration timelines, via timely response to queries from Health Authorities' and deficiencies as well as via close cooperation with other involved functions and liaison with Regulatory Authorities, where required
  • To contact and liaise directly with Regulatory Agencies as required
  • Participate in project launch meetings, review meetings and project team meetings as required

The Person

You will have skills and experience in the following:

  • BSc in a Pharmaceutical discipline or similar
  • 5+ years relevant regulatory experience in the pharmaceutical industry
  • Attention to detail and quality of documentation
  • Effective oral and written communication skills in English language as well as local language where applicable
  • Ability to work independently with direction
  • Proven ability to work effectively in a team environment
  • Ability to handle multiple projects

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.