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Regulatory affairs specialist

Dublin
beBee Careers
Regulatory affairs specialist
Posted: 13 June
Offer description

Regulatory Affairs Specialist


About the Role

We are seeking a highly skilled Regulatory Affairs specialist to support our client's growing portfolio of niche products across various markets.


Key Responsibilities:

* Update and compile product dossiers to meet current registration standards for Europe, America, and other international markets.
* Conduct due diligence on potential dossier acquisitions and review technical documents for regulatory submissions.
* Provide strategic regulatory support for license applications, site transfers, and technical variations.
* Collaborate with suppliers to manage changes across our product portfolio.
* Evaluate data from various departments and respond promptly to requests from regulatory authorities.


Requirements

To be successful in this role, you will need:

* A third-level qualification in a scientific discipline.
* At least 5 years of relevant regulatory experience in the pharmaceutical industry.


Why This Opportunity?

This hybrid role offers the flexibility to work 2–3 days per week for 6–9 months and can be based in a dynamic office environment. You will have the opportunity to contribute to innovation in pharmaceuticals and shape the future of our products.


What We Offer

In this role, you will have the chance to work in a collaborative environment that values excellence and expertise. With a strong pipeline of new product development, this is an exciting time to join our team.

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