Job Title: Senior Regulatory Specialist
About the Opportunity:
* This is a key role in our growing regulatory affairs hub for Europe, based in Dublin North.
* We are seeking experienced professionals with strong global CMC expertise to support branded pharmaceutical products across development and commercial lifecycle.
Main Responsibilities:
1. Create and coordinate high-quality CMC sections for new registrations, post-approval changes, renewals, annual reports, and line extensions. Note: Candidates should have hands-on experience with initial registrations or post-approval variations.
2. Publish responses to regulatory authority questions and perform quality reviews of CMC submissions. (Strong understanding of pharmaceutical development requirements required).
3. Evaluate global regulatory guidelines,internal policies,and agreed timelines ensuring all submissions meet them satisfactorily
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Skill Requirements-,
to succeed as a Senior Manager -Regulatory Affairs:
participating Scientific Training/conference/cpd activities/participating cross-functional teams D/A/Core Capability on M.A/Ppt Dev.),
effective project management,&Timely Communication.
The remuneration currency used is Euro (€)