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Principal Regulatory Affairs Specialist, Galway
Client:
Location: Galway, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference:
f1c089792f24
Job Views:
5
Posted:
24.04.2025
Expiry Date:
08.06.2025
Job Description:
Our client, a major multinational here in Galway, is 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 the company, internal audits, and inspections.
- Leads or compiles all materials required in submissions, license renewal, and annual registrations.
- Recommends changes for labeling, 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.
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