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Technical Regulatory Writer

Eingestellt von Harvey Nash IT Recruitment Belgium

Gesuchte Skills: Client

Projektbeschreibung

Technical Regulatory Writer
(Wavre)

For one of our client based in Wavre and active in the pharmaceutical industry we are looking for a TECHNICAL REGULATORY WRITER

DESCRIPTION

The Technical Regulatory Writer is involved in the company's regulatory activities related to new & existing products, on a domestic or international basis.

PRIMARY TASKS & RESPONSIBILITIES

* Writing CMC parts of regulatory variations
* 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
* Involvement in internal initiatives for improvement of processes/ways of working

EXPERIENCE, KNOWLEDGE & SOFT SKILL REQUIREMENTS

HARD SKILLS:

- Experience inwriting CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
- Knowledge of regulatory procedures/systems/guidance's
- 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

SOFT SKILLS:

- Manages own time to meet agreed short-term targets
- Ensures the coherence between contributions/quality of final results
- Team player

Projektdetails

  • Einsatzort:

    Wavre, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    5 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung

  • Skills:

    client

Harvey Nash IT Recruitment Belgium