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Pharmaceutical regulatory specialist

Dublin
beBeeRegulatoryAffairs
Biostatistician
Posted: 14 December
Offer description

Regulatory Affairs Associate Role

We are seeking a skilled Regulatory Affairs professional to support our publishing and submission activities.

* The ideal candidate will be responsible for the compilation of regulatory dossiers for EU and ROW submissions.
* They will assist in preparing and submitting variations, responses to regulatory queries, and other documentation.
* Operational tasks related to document authoring, including formatting, editing, reviewing, publishing, and archiving, will also be performed.

To be successful in this role, you will need:

* A Bachelor's degree in Health Sciences or a related field, or equivalent relevant experience.
* 1-3 years of experience in the pharmaceutical regulatory industry.
* A solid understanding of regulatory affairs principles, applicable regulations, and guidance documents.

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