Regulatory Manager RIM & Operations (Regulatory Information Management) – this desirable role is for a Large Pharma in North London/Hertfordshire.
Regulatory Manager RIM & Operations is responsible for leading the Operations team focused on Extended EudraVigilance Medicinal Product Dictionary (xEVMPD).
Additional responsibilities are:
- Liaising with queries on xEVMPD data and reconcile xEVMPD data with the Affiliates
- Provision of expertise during xEVMPD audits/inspections
- Generate, monitor, and ensure adherence to compliance metrics and Key Performance Indicators.
- Provide reports to senior leadership/stakeholders
- Discuss and resolve annual PV Fee Advice Note review with European Affiliates and accordingly adjust the xEVMPD database
- Maintain SOP’s
- Maintain an in-depth knowledge of xEVMPD, IDMP, SPOR, TOM, etc.; participate in external working teams (Health Authorities, Industry Forums, etc.); Communicate changes to ensure RIMS Steering Committee and other key stakeholders are kept well informed of any potential impacts
- Ensure all necessary Training and Mentoring for Staff is in place and for the development of the Team
- Appropriate Assessment of Staff in line with their development and responsibilities
- Support of internal project teams to identify and resolve issues while developing opportunities to reduce inefficiencies through new and/or improved IT solutions, business processes or tools
- Successfully operate within multi-functional teams
Experience you will need for this position:
- Life Science Degree
- In-depth knowledge and understanding of pharmaceutical science processes and standards, including xEVMPD, ISO IDMP, SPOR, Standard Terms etc. Understanding of Regulatory Life-cycle management.
- Experience using and administrating xEVMPD
- Team Management
- Working in Cross-functional Teams
- An eye for detail
- Must be proficient in Microsoft Word and Excel
A highly competitive salary package including good bonus and leading benefits awaits the successful candidate.
If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on 0203 695 9477/07 447 977 330, or by email@example.com, or apply by clicking Apply Now.