Join Our Team: Regulatory Affairs Consultant

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.

This hybrid role requires 2–3 days per week for 6–9 months and can be based in the office in Dublin or Roscommon.

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.

Why Join Us? We offer a dynamic environment where your expertise will play a vital role in shaping the future of our products and expanding our reach globally. With a strong pipeline of new product development, this is your opportunity to contribute to innovation in pharmaceuticals.

Are you ready to make an impact? Apply today to be part of a forward-thinking team that values excellence and collaboration.

Please note: Sponsorship is not available for this opportunity.

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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Regulatory Affairs Consultant