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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: January 2014
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 overPharmaceuticals)
* Experience in a research laboratory or in regulatory/drug development/public health organization

Tags: CMC, Technical, Regulatory, Réglementaires

Projektdetails

  • Einsatzort:

    Brussel, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Harvey Nash IT Recruitment Belgium