Regulatory Affairs Opportunities – Dublin and France

Due to continued growth my client – a global pharmaceutical group – have created a number of new roles within their large Regulatory Affairs department. Employing over 10,000 staff worldwide, with over 25 manufacturing operations at 18 sites on 6 continents, this company are a global supplier of branded and generic pharmaceutical products, as well as infant nutritional and consumer healthcare products in selected territories. They have recently added more products to their already extensive portfolio and are looking for a number of Regulatory professionals to join their dynamic EU headquarters in Dublin and their Corporate Office in France.

Available roles:

  • Dublin: 2 Senior Regulatory Officers, 2 Regulatory Officers
  • France: 1 Regulatory Officer

The Position

Reporting into the Compliance Regulatory Affairs manager, the main responsibilities for the roles are as follows:

Senior Regulatory Officer:

  • Managing new applications, variations and maintenance of International Marketing Authorisations’ (MA’s)
  • Gap analysis and remediation of International CMC documentation
  • Building and developing international regulatory strategy and regulatory intelligence
  • Collaborating with stakeholders to support active MA’s and related activities
  • Leading by example in completing tasks and interacting with colleagues and stakeholders
  • Team mentoring and training
  • Continuous development awareness
  • Other activities as assigned by Team Leader / Manager / Head

Regulatory Officers – Dublin and France

  • Managing new applications, variations and maintenance of International MA’s
  • Supporting New Product Introductions internationally
  • Gap analysis and remediation of international CMC documentation
  • Assist with development of international regulatory strategy and regulatory intelligence
  • Collaboration with stakeholders to support active MA’s and related activities
  • Perform assigned tasks right first time, in accordance with best practice and internal processes
  • Other activities as assigned by Team Leader / Manager / Head

Requirements

You must have the following in order to be considered:

  • Life sciences, pharmacy degree or equivalent
  • Experience in a regulatory affairs environment – Pharma, Biotech or Medical Device – may consider a Clinical Research Organisation.
  • 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: €40000 - €65000 Location: Dublin West