Shreeya Patel at CK Clinical is currently recruiting for an Associate Regulatory Publisher to join a globally successful biopharmaceutical company at their site in Cambridgeshire, UK. This Associate Regulatory Publisher role in a short-term contract position.
As Associate Regulatory Publisher, you will:
- Facilitate product development and global registration through the efficient preparation, management and tracking of regulatory documentation and systems.
- Format and publish regulatory documentation for submission, QC of regulatory dossiers, preparation and despatch of media for regulatory submissions and/or management of regulatory documentation and information.
- Regulatory submission source document review, formatting and troubleshooting, including but not limited to, MS Office, Adobe Acrobat PDF and XML ensuring documents conform to style guide and internal/external regulations
- Prepare submission ready components from source documents according to regional regulatory agency guidance
- Compile and publish submission dossiers for internal review and submission
- Document management of on-going submissions e.g. building dossier structure, sourcing documents
- Quality control of submission ready components and submission dossiers
- Prepare, dispatch and track electronic and paper media
- Maintain submission information in Regulatory Registration Tracking system
How to apply:
For more information regarding this Contract Associate Regulatory Publisher position, please contact Shreeya Patel at CK Clinical on +44 (0)1438 743 047 or email firstname.lastname@example.org. Please quote reference CL24346 in all correspondence.