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Regulatory Specialist
Eingestellt von Harvey Nash IT Recruitment Belgium
Projektbeschreibung
One of our clients, an international company in the pharmaceutical industry currently requires a Regulatory Specialist
Start: ASAP
Length: min 6 months
Location: South of Brussels
Regulatory Specialist
FUNCTION DESCRIPTION:
1) Registration Manager for Hepatitis vaccines(Havrix/Twinrix/Engerix), (50%)
* Involved in the Company's regulatory and administrative (including database entry) activities for this product line, basicallyin Europe/EMA and outside Europe (covering Emerging countries)
* Ensure the planning/dispatch/submission/follow-up/approval ofdata-packages due to Regulatory Authorities:
* Variations, Commitments, Questions & Answers, PSURs, Risk Management Plans (RMPs), Renewals, Scientific Advicesmaintenance of RA Document management database with appropriate structure/folders/naming convention in CARS
- Manage Eudralinks with EMA
PREREQUISITES
Education:
- Scientific (university degree)
Knowledge:
- EU regulations, mainly EMA
- English fluent - oral and written
- IT tools
- Project management skills
Experience:
- 2-4 year experience in the pharmaceutical industry which includeideally at least 6 month RA experience and some project management experience in a scientific environment.
Skills:
- Team spirit, flexibility and accountability, very well organized, good relationships, able to work in multi-cultural and multi-disciplinary environment
Tags: Regulatory, Submissions, EU, EMA, RA, Pharmaceutical
Start: ASAP
Length: min 6 months
Location: South of Brussels
Regulatory Specialist
FUNCTION DESCRIPTION:
1) Registration Manager for Hepatitis vaccines(Havrix/Twinrix/Engerix), (50%)
* Involved in the Company's regulatory and administrative (including database entry) activities for this product line, basicallyin Europe/EMA and outside Europe (covering Emerging countries)
* Ensure the planning/dispatch/submission/follow-up/approval ofdata-packages due to Regulatory Authorities:
* Variations, Commitments, Questions & Answers, PSURs, Risk Management Plans (RMPs), Renewals, Scientific Advicesmaintenance of RA Document management database with appropriate structure/folders/naming convention in CARS
- Manage Eudralinks with EMA
PREREQUISITES
Education:
- Scientific (university degree)
Knowledge:
- EU regulations, mainly EMA
- English fluent - oral and written
- IT tools
- Project management skills
Experience:
- 2-4 year experience in the pharmaceutical industry which includeideally at least 6 month RA experience and some project management experience in a scientific environment.
Skills:
- Team spirit, flexibility and accountability, very well organized, good relationships, able to work in multi-cultural and multi-disciplinary environment
Tags: Regulatory, Submissions, EU, EMA, RA, Pharmaceutical
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Sonstiges