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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
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
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Sonstiges