about 1 month ago
Job title: Regulatory Affairs Manager, Global Publishing
A Biopharmaceutical company in Oxfordshire are seeking a Regulatory Affairs Manager, Global Publishing to join their Regulatory Operations team. This role will be responsible for the preparation and publishing of documentation for commercial and development submissions to global health authorities. As a manager, you will be expected to provide project leadership and submission oversight of various products.
- Collaborating in submission teams, to plan and execute timely regulatory submissions primarily in eCTD format in support of investigational and marketed products
- Represent Global Regulatory Operations on regulatory teams and project teams as a subject matter expert
- Monitors global health authority regulations, guidelines, and specifications including FDA, EMA, Health Canada, and ICH for regulatory submissions to ensure compliance
- Maintain records and data in Regulatory Information Management (RIM) system
- Minimum 4-6 years of Regulatory Operations experience required, 1-2 years of direct management experience preferred
- Requires knowledge of global health authority regulations, guidelines, and specifications including, EMA, Health Canada, FDA and ICH
- Technical experience in handling eCTD Publishing tools and Submission portals is required. Experience with ISIToolBox, GlobalSubmit Review and Publish, Starting Point templates, DocuSign, and Veeva Vault is preferred
- Experience in managing and publishing of major regulatory submissions for investigational or marketed products to global health authorities in eCTD format.
Salary and benefits:
A competitive salary, annual bonus and wider benefits package is on offer with this role
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org