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Technical Regulatory Expert
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Consultant
Projektbeschreibung
One of our clients, a multinational company in the pharmaceutical industry, currently requires a Technical Regulatory Consultant
Start: ASAP
Length: 24 months
Location: South of Brussels
FUNCTION 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
PREREQUISITES
Education
* University level (Life Sciences background is preferred)
Knowledge
* Experience is 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/drugdevelopment/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 with working with Biologics (if possible preferred over Pharmaceuticals)
* Experience in a research laboratory or in regulatory/drug development/public health organization
Tags: Regulatory, CMC, Pharmaceutical, EU, US, Module 2
Start: ASAP
Length: 24 months
Location: South of Brussels
FUNCTION 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
PREREQUISITES
Education
* University level (Life Sciences background is preferred)
Knowledge
* Experience is 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/drugdevelopment/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 with working with Biologics (if possible preferred over Pharmaceuticals)
* Experience in a research laboratory or in regulatory/drug development/public health organization
Tags: Regulatory, CMC, Pharmaceutical, EU, US, Module 2
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Organisation/Management