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Technical Regulatory Expert

Eingestellt von Harvey Nash IT Recruitment Belgium

Gesuchte Skills: Support, Client

Projektbeschreibung

Our client, a multinational company in the pharmaceutical industry, requires a Technical Regulatory Expert

Start: 1/6/13
Length: 6 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 or international basis.

KEY RESPONSIBILITIES:

* Writing Chemistry, manufacturing and controls (CMC) on:
o "Facility and equipment" parts
o New files for US regulatory File
* Lead and coordination for Core Files documents on the Belgian sites, in collaboration with QA system organization.
* Manage and schedule with Production, Technical, Quality Control, Quality Assurance the writing/review process to ensure timely completion.
* Ensure the coordination with the departments involved in the writing/review process
* Writing and support US regulatory affairs Responses to Questions raised by Regulatory Authorities
* Monitor that supportive data provided by other departments are compliant
* Report significant issues

PREREQUISITES:

Education:
* University level (+) Life Sciences background
* equivalent by experience

Knowledge:

* Regulatory procedures/systems/guidances
* Biologic process and process equipment
* Qualification/Validation principles
* EU/US variations policy

Experience:

* Writing CMC (technical) parts of regulatory documents (registration files or variations)
* Working with Biologics (if possible preferred over Pharmaceuticals)

Specific Skills:

* Good level of spoken and written English
* Manages own time to meet agreed short-term targets
* Good communication skills
* Writing skills
* Analytical skills, creative and critical mind
* Ensures the coherence between contributions/quality of final results
* Team player

Projektdetails

  • Einsatzort:

    Brussel, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash IT Recruitment Belgium

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