Regulatory Records and Data Manager
Life Sciences Pharmaceuticals
An excellent opportunity has arisen for a Regulatory Records and Data Manager to join a global pharmaceutical company at their site based in Uxbridge.
This is a chance to work with a global leader and world-renowned organisation. As a Regulatory Records and Data Manager, you will be responsible for ensuring the data quality and consistent and effective use of registration data systems in order to support the companies Regulatory and Pharmacovigilance obligations.
In this role, you will be responsible for ensuring delivery of Regulatory Records & Data Management (RRDM) initiatives and projects and for the oversight of operational teams ensuring the timely execution of RRDM based requests.
Other responsibilities will include:
• Efficiently delivering on-time completion of all Regulatory Records & Data Management (RRDM) activities assigned in compliance with internal and external procedures/regulations,
• Leading and motivating teams of Regulatory Records & Data Management associates, ensuring appropriate knowledge and competency is built and maintained to support existing and emerging workload,
• Leading initiatives and projects to support evolving internal and external regulatory requirements impacting the Regulatory Information Management processes such as Registration Tracking, EVMPD, IDMP and CMC Technical Details
• Partnering with GRPD Regulatory Systems and external vendors to optimize delivery and use of regulatory data management systems and associated processes,
• Collaborating with Regulatory Operations functions within the company to maximize the alignment and efficiency of Registration Data Management across all Business Units,
• Defining system procedures, including reports, to support Business Processes effectively and manage change control procedures to ensure full impact assessment and robust implementation of change,
• Identify cases of potential non-compliance with internal and external procedures and follow appropriate procedures to investigate and, where necessary, identify risks, appropriate corrective actions and prevent future issues,
• Develop metrics, evaluate and improve performance of the RRDM team.
Previous knowledge and some experience of regulatory affairs/ operations would be an advantage. This is an exciting opportunity and we look forward to receiving your application.
For further information please feel free to contact Helen at CY Partners on 0191 477 4733 or [email protected]