Specialist, Electronic Submissions

CK Group are recruiting for the role of Specialist, Electronic Submissions to join a Global Pharmaceutical company. Flexible home working is available.

Key duties will include, but not limited to:

• Publish Marketing Authorisation (MA) Application and all associated maintenance submissions for new and existing products in eCTD format or NeeS format, as required, in a timely manner to meet deadlines and Service Level Agreements.
• Perform technical validation of electronic submissions to ensure compliance with externally set criteria before delivery to the Regulatory Users for internal review/approval, dispatch to Health Authority and archiving of each submission with agreed timelines.
• Act as point contact/ Subject Matter Expert (SME) for publishing queries within the central RA, EU Affiliate teams and cross-functional disciplines
• Contribute to the creation and maintenance of internal guidelines for regulatory systems and provide system/process training within scope of thisrole
• Develop and maintain a working knowledge of publishing software and other regulatory systems within scope of this role.

Your Background:

• BSc degree with focus on Information Management, BioScience, Business Administration or equivalent preferred
• Profound knowledge in the regulatory operations sector, especially in publishing and dossier submission management
• Expertise with MS Office, Adobe Acrobat Professional, Document Management Systems _DMS), eCTD Publishing Software and registrations management systems and associated global publishing processes and related regulations.

Apply: Entitlement to work in the UK is essential. For more information or to apply for this Specialist, Electronic Submissions position, please contact Ashleigh Williamson on 01438 842 978 or email awilliamson@ckgroup.co.uk. Please quote reference 52361.Surrey. The role is fully remote.

Apply: Entitlement to work in the UK is essential. For more information, please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 52380.iology position please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 52437.

It is essential that applicants hold entitlement to work in the UK.

IND180