Regulatory Affairs Officer

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  • Full Time
  • Dublin

Our Client is looking for a Regulatory Affairs Officer to join their team. This is a wonderful opportunity for you if you have experience in this industry and want to work in an environment where progress and dedication is recognised. This is a hybrid role.

Key Responsibilities:To prepare and project manage high quality registration dossiers for approval by Regulatory Authorities in Europe.

Represent the company on Task Forces, Data Sharing Groups and Industry Forums.

Commission studies with Contract Research Organisations. Monitor progress of studies to ensure target dates are maintained.

Keep up to-date with national and EU regulatory guidelines.

Build and maintain strong relationships with Regulatory Authorities, Consultants, CRO’s, Internal departments.

Mentor and Train junior Regulatory staff as required.

Comply with the Lean Principles being embedded throughout the organisation.

Participate in Continuous Improvement Initiatives to further develop department functions.

Competencies & Experience required:3+ years’ experience in European Regulatory Affairs.

Experience with both active substances and products.

Detailed understanding of IT Systems and Database Administration desirable.

Good time management and strong on attention to detail.

Excellent Communication skills.

Strong analytical and associated problem-solving ability.

Effective decision making.

Able to work under supervision or on own.

Knowledge and proficient in the use of SharePoint, Microsoft Word, Excel etc.

Qualifications:Minimum of a bachelor’s degree, in Science or a related discipline.

Salary:

€50K to €60K per annum & benefits

Upload your CV/resume or any other relevant file in pdf, doc or docx formats. Max. file size: 32 MB.

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