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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

Projektdetails

  • Einsatzort:

    Brussel, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    24 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Organisation/Management

  • Skills:

    consultant

Harvey Nash IT Recruitment Belgium

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