Regulatory Affairs Executive
2 weeks ago
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Regulatory Affairs Executive - Abbott Pharmaceutical (Based in Binh Duong), SligoClient:Abbott
Location:Sligo, Ireland
Job Category:Other
EU work permit required:Yes
Job Reference:4d0a8a4be685
Job Views:2
Posted:28.03.2025
Expiry Date:12.05.2025
Job Description:RESPONSIBILITIES:
Registration of New and Existing Products- Reviews and compiles registration dossier for prompt renewal/initial/variation registration.
- Maintains Marketing Authorizations in compliance with local regulations by ensuring that corporate regulatory processes, SOP's and systems (e.g. change control, product labelling, etc.) are in place.
- Ensures availability of updated registration documents/samples.
- Weekly follow up with the authorities as needed.
- Fast requisition of dossier and check requests.
- Initiates/monitors/updates Regulatory Report in timely manner.
- Register and compiles registration dossier for promotional material.
- Ensures all promotional materials are lawfully compliant.
- Be aware of coming new regulation/change that impact regulatory or business.
- Inform head of Department/contacts all changes and upcoming new regulations.
REQUIREMENTS:
Work Experience:- Knowledge of regulations and standards.
- More than 3 years relevant experience in regulatory affairs.
- Analytical thinking.
- Fluent in English – written and spoken communication skills.
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