Technical Regulatory Expert

For one of our clients working in the pharmaceutical industry, we are currently looking for a TECHNICAL REGULATORY EXPERT

Start: ASAP
Duration: min 6 months + extension
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 or international basis.

KEY RESPONSIBILITIES:

* Writing CMC parts of regulatory variations for EU and International countries
* Writing Module 2 of regulatory files derived from completed eCTDModules 3
* Writing IMPDs as far as CMC information is concerned
* Writing Responses to Questions raised by Regulatory Authorities onCMC 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/drug development/public health organization
* Manages own time to meet agreed short-term targets
* Ensures the coherence between contributions/quality of final results
* Team player

Experience:

* Experience is 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