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Regulatory affairs manager

Dublin
Cpl Solutions
Regulatory affairs manager
Posted: 4 July
Offer description

Regulatory Affairs Manager - NEW OPPORTUNITY Thornshaw Scientific, on behalf of their client, a global pharmaceutical company, has a new opportunity for a Regulatory Affairs Manager to join their team in Dublin.
This is a full-time, hybrid position reporting to the Global Regulatory Affairs Associate Director.

Responsibilities: Lead planning, execution, tracking, and reporting of operational registration and lifecycle management projects for company products.
Promote regulatory best practices, strategy, process efficiencies, and effective communication across teams.
Ensure high-quality submissions including Marketing Authorization Transfers, CMC variations, initial MAA filings, labeling updates, renewals, and related documentation.
Maintain effective communication with Regulatory Authorities and internal teams (CMC, Quality, PV, Legal, Supply Chain, Commercial, Medical, Clinical, QA) and external partners.
Manage junior team members and coordinate with global stakeholders.
Qualifications & Experience: Degree in Pharmacy, Science, or related field.
Over 5 years of regulatory experience in the pharmaceutical industry, focusing on lifecycle maintenance of marketed products in Europe or emerging markets.
Experience with EU DCP and MRP MAAs, CTD dossier preparation, and project management.
Excellent communication skills.
Application: For full details, email your CV to or call Tina at +353 1 2784701.

Additional Information: Seniority level: Mid-Senior level Employment type: Full-time Job function: Legal This job posting is active and not expired.

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