Social network you want to login/join with:
Regulatory Affairs Executive - Abbott Pharmaceutical (Based in Binh Duong), Sligo
Client:
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
1. Reviews and compiles registration dossier for prompt renewal/initial/variation registration.
2. 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.
3. Ensures availability of updated registration documents/samples.
4. Weekly follow up with the authorities as needed.
5. Fast requisition of dossier and check requests.
6. Initiates/monitors/updates Regulatory Report in timely manner.
Registration of Promotion Materials
1. Register and compiles registration dossier for promotional material.
2. Ensures all promotional materials are lawfully compliant.
3. Be aware of coming new regulation/change that impact regulatory or business.
4. Inform head of Department/contacts all changes and upcoming new regulations.
REQUIREMENTS:
Work Experience:
1. Knowledge of regulations and standards.
2. More than 3 years relevant experience in regulatory affairs.
Competency:
1. Analytical thinking.
Language Skill:
1. Fluent in English – written and spoken communication skills.
#J-18808-Ljbffr