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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
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
Geforderte Qualifikationen
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Kategorie:
Sonstiges