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Technical Regulatory Expert
Eingestellt von Harvey Nash IT Recruitment Belgium
Projektbeschreibung
One of our clients in the pharmaceutical industry currently requires a Technical Regulatory Expert
Start: ASAP
Length: min 6 months
Location: South of Brussels
TECHNICAL REGULATORY EXPERT:
MISSION DESCRIPTION:
The Technical Regulatory Expert is involved in the company's regulatory activities related to new & existing products, on a domestic orinternational basis.
KEY RESPONSIBILITIES:
* Writing CMC parts of regulatory variations for EU and International countries
* Writing Module 2 of regulatory files derived from completed eCTD Modules 3
* Writing IMPDs as far as CMC information is concerned
* Writing Responses to Questions raised by Regulatory Authorities on CMC matters
* Update of internal tracking system linked to their CMC activities
PREREQUISITES:
Education
* University level (Life Sciences background is preferred)
Knowledge
* Experience in writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
* Knowledge of regulatory procedures/systems/guidances
* Good level of spoken and written English
* Experience working with Biologics (if possible preferred over Pharmaceuticals)
* Knowledge of the EU/US variations policy
* Experience in a research laboratory or in regulatory/drug development/public health organization
* Manages own time to meet agreed short-term targets
* Ensures the coherence between contributions/quality of finalresults
* Team player
Experience
* Experience in writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
* Experience working with Biologics (if possible preferred over Pharmaceuticals)
* Experience in a research laboratory or in regulatory/drug development/public health organization
Tags: CMC, Technical, Regulatory, Réglementaires
Start: ASAP
Length: min 6 months
Location: South of Brussels
TECHNICAL REGULATORY EXPERT:
MISSION DESCRIPTION:
The Technical Regulatory Expert is involved in the company's regulatory activities related to new & existing products, on a domestic orinternational basis.
KEY RESPONSIBILITIES:
* Writing CMC parts of regulatory variations for EU and International countries
* Writing Module 2 of regulatory files derived from completed eCTD Modules 3
* Writing IMPDs as far as CMC information is concerned
* Writing Responses to Questions raised by Regulatory Authorities on CMC matters
* Update of internal tracking system linked to their CMC activities
PREREQUISITES:
Education
* University level (Life Sciences background is preferred)
Knowledge
* Experience in writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
* Knowledge of regulatory procedures/systems/guidances
* Good level of spoken and written English
* Experience working with Biologics (if possible preferred over Pharmaceuticals)
* Knowledge of the EU/US variations policy
* Experience in a research laboratory or in regulatory/drug development/public health organization
* Manages own time to meet agreed short-term targets
* Ensures the coherence between contributions/quality of finalresults
* Team player
Experience
* Experience in writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
* Experience working with Biologics (if possible preferred over Pharmaceuticals)
* Experience in a research laboratory or in regulatory/drug development/public health organization
Tags: CMC, Technical, Regulatory, Réglementaires
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Sonstiges