- Act as an ad interim Regulatory Affairs Manager
- Prepare and file applications for Marketing Authorisations through the national, the mutual recognition or decentralised procedure
- Prepare and file renewals and variations to Marketing Authorisations through the national, the mutual recognition or decentralised procedure
- Provide specialised advice and interpretation of national and European legislation
- Create, review or update the “quality” parts of dossiers in line with the latest relevant EU guidelines, Eur. Ph. monographs etc.
- Reformat dossiers to the CTD format
- Regulatory Compliance
- NeeS compiling for regulatory submissions
- CESP submission
- Artwork review
