Regulatory Affairs Roles – Global Pharma Group

This global pharma group employs over 10,000 staff worldwide, with over 25 manufacturing operations at 18 sites on 6 continents. They 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 across Compliance and Submissions.

The Position

Reporting into the Regulatory Affairs manager, the main objectives for the Submissions and Compliance roles include the following:

Submissions:

  • Ensure timely preparation and compilation of registration dossier components in accordance with EU standards and corporate requirements
  • Manage international regulatory submissions according to company strategy and ensure registration deadlines are met by responding to Health Authorities’ queries and deficiencies in a timely manner and by liaising with other departments to support the timely introduction of new product into markets
  • Maintain assigned products’ Marketing Authorisations via submission of the appropriate variations and renewals and communication of these approvals to the relevant departments
  • Build departmental awareness of local regulatory requirements in global markets
  • Compile regulatory component of annual product review and PSUR
  • Archive the registration documentation according to internal standards; introduce and regularly update internal RA databases
  • Perform assigned tasks with the highest quality and in accordance to established internal time-lines and guidelines

Compliance:

  • Manage new applications, variations and maintenance of International MA’s
  • Support 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
  • 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: €40000 - €65000 Location: Dublin West