Regulatory Dossier Manager

14444Contract £19 - £22 Per Hour Hybrid South East - United Kingdom Updated on: 01-04-2025

We are currently looking for a Regulatory Dossier Manager to join a leading Pharmaceutical company based in the London/Surrey border. As the Regulatory Dossier Manager, you will be responsible for the operational management of dossier build and/or publish of regional and/or national regulatory dossiers to designated Health Authorities (HAs).

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Regulatory Dossier Manager will be varied; however, the key duties and responsibilities are as follows:

1. Monitor document receipt, following up with contributors, and managing translations for assigned submissions.
2. Execute dossier technical build and publish, ensuring compliance with global standards and practices.
3. Submit dossiers to Health Authorities or dispatching to the applicable country office, adhering to regulatory submission milestones.
4. Engage with Submission Managers, Publishing leaders, and other key representatives to agree on processes for re-using submission documentation for multiple markets.

ROLE REQUIREMENTS:

To be successful in your application to this exciting role as the Regulatory Dossier Manager, we are looking to identify the following on your profile and past history:

1. Relevant degree in Pharmacy, Life Sciences, Business, or Information Technology.
2. Proven industry experience in Regulatory Affairs submissions and dossier management.
3. A working knowledge and practical experience with publishing and document management tools.

Key Words: Dossier Manager / Regulatory Submissions / Pharmaceutical / Health Authorities / Document Management / Publishing / Compliance / Regulatory Science / Submission Management / Regulatory Affairs