Social network you want to login/join with:
Principal Regulatory Affairs Specialist, Galway
col-narrow-left
Client:
Location:
Galway, Ireland
Job Category:
Other
-
EU work permit required:
Yes
col-narrow-right
Job Reference:
f1c089792f24
Job Views:
4
Posted:
03.06.2025
Expiry Date:
18.07.2025
col-wide
Job Description:
Our client a major multinational here in Galway are looking to hire a Principal Regulatory Affairs Specialist on an initial 12 month contract.
Responsibilities:
* Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
* Leads or compiles all materials required in submissions, license renewal and annual registrations.
* Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking / control systems.
* Keeps abreast of regulatory procedures and changes.
* May direct interaction with regulatory agencies on defined matters.
* Recommends strategies for earliest possible approvals of clinical trials applications.
Requirements:
* Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
* May have broad knowledge of project management.
* Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
#J-18808-Ljbffr