About the Role:
My Client based in Hertfordshire is currently looking for a Regulatory Publisher to join them on a Contract basis ASAP.
* The function within Regulatory Affairs is responsible for the planning, creation and shipping of high-quality CTD and eCTD dossiers, training authors on and assisting them with source document formatting, maintaining appropriate software solutions and systems to support business processes incl. electronic filings to key authorities.
* Further, this function manages regulatory affairs' archiving, SOPs and regulatory information data bases
* Ensuring compliance of paper and electronic dossiers with health authority requirements worldwide with the aim to be fully electronic wherever possible. Currently via FDA portal and EMA portal (CESP) and MHRA portal.
* Publishing for and dispatch of paper and electronic dossiers to health authorities worldwide
* Identifying system requirements as well as defining and delivering well-suited solutions that meet the needs of authors regarding the preparation and management of source documents
* Maintaining appropriate and compliant archiving solutions for the RA department.
* Generating and maintaining SOPs and manuals for the RA department as required.
* Maintaining and evolving electronic publishing systems for paper and electronic dossiers
* Implementing new regulatory affairs systems (e.g. regulatory information management, document management)
* Submitting electronic applications via FDA, EMA, MHRA Portals
* 3-4 years Regulatory experience
* eCTD and Nees experience
* Excellent verbal and written communication skills
* Excellent interpersonal skills
Job type: Contract
Duration: 6 Months
If you are interested in this role or know anyone who might be please respond with an up to date CV and I will be in touch.
Also, please feel free to join my LinkedIn group, created specifically for roles within Regulatory Affairs (Link Below).