Regulatory Affairs Consultant

Regulatory Affairs Consultant

IQVIA

Dublin or Roscommon, Ireland

Are you a skilled Regulatory Affairs professional with strong technical knowledge and experience in the pharmaceutical industry? We are seeking an exceptional Regulatory Affairs Consultant to support our client’s growing portfolio of niche, value-added products across various markets.

Role Overview:

As a Regulatory Affairs Consultant, you will:

• Update and compile dossiers to meet current registration standards for Europe, America, and other international markets.
• Conduct due diligence on potential dossier acquisitions and author/review technical documents for Modules 1, 2, and 3.
• Provide strategic regulatory support for dossier submissions, license applications, site transfers, and technical variations.
• Respond promptly to requests from regulatory authorities and evaluate data from various departments.
• Collaborate with CMOs to manage changes across our product portfolio.
• Review advertising materials in line with relevant codes and regulatory guidance.

What We're Looking For:

• Education: Third-level qualification in a scientific discipline.
• Experience: At least 5 years of relevant regulatory experience in the pharmaceutical industry.

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