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.
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.
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.
- 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
- 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