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Expert regulator of medical products

Dublin
beBeeRegulatoryAffairs
Posted: 4 December
Offer description

Regulatory Affairs Expert

We are looking for a skilled Regulatory Affairs Executive to join our team. The ideal candidate will have experience in preparing regulatory dossiers and submitting them to European health authorities.


Key Responsibilities:

* Prepare and submit regulatory dossiers to European health authorities
* Compile administrative documents, taking into account country-specific requirements
* Assist in drafting administrative and quality variation dossiers
* Prepare dossiers electronically in eCTD format
* Collaborate with operational teams for electronic publication and submission
* Update regulatory databases and tools

The successful candidate will be self-motivated, enjoy working as part of a team, and have excellent relational skills and organizational abilities. A scientific background is an asset for dossier preparation. English language proficiency and Microsoft Office skills are essential.

As a Regulatory Affairs Executive at Viatris, you will contribute to building a diverse, inclusive, and authentic workplace. We foster collaboration and encourage employees to realize their full potential. Our commitment to sustainability and social responsibility empowers people to live healthier lives.


Requirements:

* Two- or three-year post-secondary degree (or equivalent) and significant experience in a similar role
* Excellent relational skills, strong organizational abilities, commitment to quality, and ability to meet deadlines
* English language proficiency and Microsoft Office skills

If you are a motivated and detail-oriented individual who thrives in a fast-paced environment, we invite you to apply for this exciting opportunity.

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