We have a temporary opportunity for a junior consultant to support publishing, verification, coordination and dispatch of HA compliant, for worldwide regulatory submissions for global product portfolio.
• Create, assemble and publish electronic submissions per regulatory requirements with a focus on maintenance submissions worldwide (variations, Response to List of Questions etc)
• Coordinates internal publishing activities and liaises with cross functional teams and document authors to assist with timelines and deliverables related to submission documents
• Conducts quality control review tasks
• Bachelor’s Degree in life sciences or a relevant discipline with prior industry experience
• Familiar with regulatory requirements and good knowledge on regulatory submission format, particularly CTD/eCTD
• Strong interpersonal communication skills and ability to work effectively in cross-functional teams
• Proficiency with MS office and publishing software (e.g. eCTDXpress, DocuBridge, etc.)
This is temporary contract which will be home based to start with and further on office based in Basel. Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.