Description
We are looking for several Scientific Writer - Regulatory CMC expert for our client, a great pharmaceutical company in Walloon Brabant.
Place: Walloon Brabant
Start: ASAP
Duration: 6 months with possibility of renewal
The Regulatory CMC Expert 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 life cycle variations/supplement for all destinations
Writing Module 2 of regulatory files derived from completed eCTD Modules 3
Writing Responses to Questions raised by Regulatory Authorities on CMC matters
Support to transversal Regulatory CMC activities
PREREQUISITES
Education
University level (Life Sciences background is preferred)
Knowledge
Experience is writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
Knowledge of regulatory procedures/systems/guidances
Good level of spoken and written English
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
Manages own time to meet agreed short-term targets
Ensures the coherence between contributions/quality of final results
Experience
Experience is writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
Experience working with Biologics (if possible preferred over Pharmaceuticals)
Experience in a research laboratory or in regulatory/drug development/public health organization
You:
Good communication skills - Team spirit
Team player/ability to work under pressure and time constraints
Good writer in English