As Head of Regulatory Operations, you will be responsible for all communication to the regulatory authorities including regulatory submissions. You will be responsible for ensuring that the regulatory submissions are compliant with current guidelines.
The main responsibilities of this Head of Regulatory Operations role will include:
- Managing all communications with Regulatory Authorities.
- Ensuring an appropriate tracking system is in place and maintained.
- Creating and managing the submission of regulatory dossier across different regions and ensuring compliance with the appropriate authorities.
- Ensuring the format of the dossiers are compliant with internal and external guidelines.
- Keeping up to date with changes in guidelines and legislations and communicating these throughout the department.
- Providing advice and guidance to cross functional teams on the structure of regional dossiers.
- Helping develop the operations department and providing advice on process improvements.
The ideal candidate for this Head of Regulatory Operations role will have the following experience and attributes:
- Must have previous regulatory operations experience.
- Line management experience.
- Strong knowledge and understanding of EU regulatory authorities.
- Process and detail driven.
- Experience with CTD highly beneficial.
Apply now
For more information, or to apply for this Head of Regulatory Operations role, please contact Jonathan Hart-Smith on 01438 743 047 or email jhartsmith@ckclinical.co.uk.
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