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Technical Regulatory Writer

Eingestellt von Harvey Nash IT Recruitment Belgium

Projektbeschreibung

One of our clients, an international company in the pharmaceutical industry currently requires a Technical Regulatory Writer

Start: ASAP
Length: min. 6 months
Location: South of Brussels

Scope:

The Technical Regulatory Writer 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
- 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

Prerequisites:

Education: Scientific University Degree

Knowledge/skills:

- Experience in writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
- Knowledge of regulatory procedures/systems/guidance
- 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
- Very good level of spoken and written English

Soft skills:

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

Tags: CMC, Regulatory, eCTD, module 2, pharmaceutical

Projektdetails

  • Einsatzort:

    Brussel, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Harvey Nash IT Recruitment Belgium

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