10 months ago
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.
- 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
- 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
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.
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