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Regulatory Affairs and Compliance Officer

Regulatory Affairs and Compliance Officer

Regulatory Affairs & Compliance Officer

Are you looking to further your career in a Regulatory Affairs role? Next Generation is currently recruiting for a Senior Regulatory Affairs Specialist for a Global Pharmacetuical company based in Dublin. The successful candidate will be responsible for the review and preparation of regulatory documents.

Responsibilities

  • Responsible for preparing new product, product renewal and variation applications
  • Management of applications through to completion
  • Liaising with R&D, Quality, Medical Affairs and Business Development departments
  • Prepare responses to queries from Regulatory authorities on new and existing products
  • Provide support to the Quality department to coordinate and log change controls, deviations and product quality reviews
  • Ensure the Regulatory Affairs documentation control system is kep up to date
  • Lead regulatory compliance change control assessments
  • Support complex regulatory strategy issues to develop suitable solutions

Experience

  • Minimum BSc. in Life Science or Pharmacy related fields
  • 2+ years' experience in Pharmaceuticals is essential
  • Experience in a previous regulatory affairs role is desirable

 

Interested?

The Next Step for you...

Should this position be of interest to you please forward your CV to Renata Kormann from Next Generation Recruitment or alternatively call on the main line on +353 1 6629120.

Next Generation are specialists in Engineering, Data Science, Digital, Finance, IT Contract, IT Permanent, Life Sciences, Supply Chain, Procurement & Operations. Applications are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and monitoring purpose. Please read our Data Protection Policy on our website.