Social network you want to login/join with:
Regulatory Affairs Manager - Pharma EU, Dublin
Client:
Cpl
Location:
Dublin, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
a596dab51f44
Job Views:
2
Posted:
27.04.2025
Expiry Date:
11.06.2025
Job Description:
JOB DESCRIPTION FORM
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.
Reporting to the Global Regulatory Affairs Associate Director, this is a full-time/hybrid position.
The role & Responsibilities:
* Lead planning, execution, tracking, and reporting of operational registration and lifecycle management projects for company products.
* Promote regulatory best practices, strategy, process efficiencies, communication, status reporting, and project delivery.
* Support corporate growth and patient treatment options through high-quality registration processes and team collaboration.
* Manage junior team members (internal and external).
Additional responsibilities include acting as a responsible manager for regulatory projects, managing regulatory submissions such as MA transfers, CMC variations, initial MAA filings, labeling updates, renewals, and related activities, ensuring effective communication with authorities and internal teams, and external partners.
Qualifications & Experience:
* Pharmacy or scientific degree(s).
* Over 5 years of pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and emerging markets.
* Experience with CTD documents, EU DCP, and MRP MAAs.
For full details, please email your CV or call Tina at the provided number. Thornshaw Scientific is a leading life sciences agency and part of the CPL Group.
#J-18808-Ljbffr