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Regulatory Dossier Manager

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. As the Regulatory Dossier Manager, you will monitor document receipt, following up with contributors, and managing translations for assigned submissions.

2. As the Regulatory Dossier Manager, you will execute dossier technical build and publish, ensuring compliance with global standards and practices.

3. As the Regulatory Dossier Manager, you will submit dossiers to Health Authorities or dispatching to the applicable country office, adhering to regulatory submission milestones.

4. As the Regulatory Dossier Manager, you will 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 Afffairs 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
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
 

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.

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