An emerging global pharmaceutical enterprise is looking for a Head of Regulatory Operations to join their team based in Essex, UK.
As Head of Regulatory Operations, you will mainly be responsible for all communication to the regulatory authorities including regulatory submissions. You will also be responsible for ensuring that the regulatory submissions are compliant with current guidelines.
Further key responsibilities of this Head of Regulatory Operations role will include:
- To manage all communications with Regulatory Authorities.
- To ensure an appropriate tracking system is in place and maintained.
- To create and manage the submission of regulatory dossier across different regions and ensure compliance with the appropriate authorities.
- To ensure the format of the dossiers are compliant with internal and external guidelines.
- To keep up to date with changes in guidelines and legislations and communicate these throughout the department.
- To provide advice and guidance to cross functional teams on the structure of regional dossiers.
- To help develop the operations department and provide advice on process improvements.
To be considered for this Head of Regulatory Operations job you will be process and detail driven and will have demonstrable experience in the following:
- Regulatory operations
- Line management experience.
- Strong knowledge and understanding of EU regulatory authorities.
- Experience with CTD
For more information, or to apply for this Head of Regulatory Operations job, please contact Meera Pattni on +44 (0)1438 743047 or email: email@example.com.
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