Senior Regulatory Affairs Officer

Our client is a global leader within the pharmaceutical world and is one of the largest MA holders within the EU. Due to continued success, they are looking for a number of Senior Regulatory professionals to join their compliance team to be based in their EU headquarters in West Dublin. The positions will initially be 24-month contracts with the view to permanency but offer standard benefits.

The Position

As Senior RO for Compliance you will be responsible for the following:

  • Managing new applications, variations and maintenance of International Marketing Authorisations.
  • Carrying out gap analysis and remediation of International CMC documentation.
  • Building and developing regulatory strategy and regulatory intelligence within the international markets my client operate in.
  • Collaborating with stakeholders to support active Marketing Authorisations and related activities.

Requirements

You must have the following in order to be considered:

  • Life sciences, pharmacy degree or equivalent.
  • 3+ years’ experience in a regulatory affairs environment – Pharma, Biotech or Medical Device.
  • Knowledge of EU and other regions current registration and dossier requirements.
  • IT – Word, Excel, Access, Powerpoint.
  • Fluent English and eligibility to work in EU.

Benefits

  • Competitive Salary
  • Performance Related Bonus
  • Health Care Allowance
  • Employee Assistance Programme
  • Defined Contribution Pension Scheme
  • Increases in Annual Leave Entitlement based on Length of Service
  • Flexi-time
  • Paid Maternity/ Adoptive/ Paternity Leave
  • Life Assurance
  • Permanent Health Insurance (PHI)
  • Recognition Awards

To find out more about these opportunities and others apply online to add your details or contact Gillian McMurrough directly on +353 1 6321827 | TEXT 0871213548 for a confidential discussion.

Salary: €45000 - €55000 Location: Dublin West