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Senior Regulatory Affairs Officer

Location: Dublin, Republic of Ireland Salary:
Sector: Regulatory Affairs Type: Permanent

One of Ireland's leading Pharmaceutical companies based in Dublin are looking for a Senior Regulatory Affairs Officer to join their expanding team. This company has one of the largest Regulatory Affairs departments in the industry, and fosters an environment of growth and innovation. You will gain experience across a broad range of therapeutic areas of own brand, leading partner brands and generics medicines.

The Role:

  • Manage new applications, variations and maintenance of International MA's
  • Gap analysis and remediation of International CMC documentation
  • Lead project teams or working groups as directed by management
  • Provide mentoring and support for new starters and less experienced team members
  • Representing RA Compliance at relevant meetings / telecons / WebExs
  • Peer review of dossier documents for accuracy, completeness and compliance
  • Timely escalation of issues causing delays with dossier development

Education and Experience:

  • Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
  • Minimum 3 years experience in a regulatory affairs environment
  • Knowledge of EU and other regions current registration and dossier requirements
  • Experience with systems and tools specific for RA and pharmaceutical sector

Excellent salary and benefits package on offer with this role

Not sure yet? No CV ready? Call me on 01-8883477 for more information!

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales