Regulatory Operations Manager - Permanent - HertfordshireAre feeling the need for a change? Is your current Regulatory position not quite hitting the spot and are now realising you are in need of a new focus and direction?
My client based in the Southeast is now looking for an experienced Regulatory Operations Manager within
We are looking for candidates with extensive experience of XEVMPD data management, submissions and related communication with teams and health authorities.
Duties and responsibilities will include but not limited to the following:
- Lead the Operations team responsible for Extended EudraVigilance Medicinal Product Dictionary (xEVMPD)
- (Article 57) submissions to ensure compliance with current regulations
- Respond to Health Authority queries on xEVMPD data as required and reconcile xEVMPD data with the Affiliates
- Provide expertise during xEVMPD audits/inspections and support the process by providing reports and
- Generate, monitor and ensure adherence to compliance metrics and Key Performance Indicators. Provide
- Reports to senior leadership/stakeholders and escalate issues as needed.
- Coordinate Annual PV Fee Advice Note review with EEA Affiliates, ensuring any corrective actions have been
- Made in the xEVMPD database as instructed by the Affiliates.
- Manage xEVMPD data requests. Generate the reports, analyze the data and distribute to appropriate
We are offering a very competitive salary and benefits package for this new and exciting opportunity.
If this is of interest to you, please do get in touch.
The candidate must have the rights to work in the location stated in the job advert.
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