Expert Regulatory Submission Publisher

On behalf of our client in the Life Science industry, Harvey Nash is looking for a Expert Regulatory Submissions Publisher for a 6 month project in Switzerland.

The role

- Responsible for all global publishing, verification, dispatch and management of submission drug dossiers (e-CTD, NEES, Paper)
- Liaise with publishing teams located in US, Switzerland and India
- preparation and execution of paper submissions to global health Authorities including EMA, FDA, Swiss Medic, LATAM, ROW
- Support implementation of Technical Format requirements
- Ensure adherence to international standards and processes, as well as authority requirements
- Partner with other department coordinators to organise and negotiate target submission date
- Take part in improving submission process and knowledge transfer
- Communicate with teams in a Matrix structure

Requirements

- 5-8 years' experience in Regulatory Affairs within Pharma/Biotech company
- Experience in electronic submissions publishing, dossier management and dispatch of global drug dossiers
- HA submission publishing knowledge
- Global submission exposure preferably EU, US, Asia, Latin America
- BSc/MSc in scientific related field or equivalent
- Fluent English required, additional languages are a plus

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) For further details feel free to call me. Im looking forward to receiving your application.