Purpose of role
Provide leadership and oversight of regulatory operational activities and deliverables in line with business priorities. Ensure Regulatory Affairs operational activities are delivered via efficient & optimised processes as per agreed timelines. Manage the RA forecast prioritisation and ensure effective and quality delivery from external vendors.
Key Responsibilities – Strategic, Financial, Resource, Management, Decision Rights, Key interactions (Internally / Externally)
- Responsible for ensuring RA operational activities are delivered as per agreed targets in a consistent and efficient manner and with the right quality.
- Responsible for ensuring operational excellence in delivery of regulatory output by external vendors.
- Utilising effective processes and adequate oversight, and in collaboration with the asset regulatory and/or project leads, ensure operational delivery is in alignment with product regulatory strategies and business needs.
- Responsible for the RA forecasting and planning and ensuring effective prioritisation of workload
- Act as initial escalation point for Regulatory Affairs Process related queries from within the organisation and from vendors.
Tasks that individual will carry out:
- Provision of effective RA knowledge and process expertise to ensure vendors are providing effective, efficient service and are utilising processes optimised for Mundipharma
- Oversight of RA delivery service output from vendors to ensure that it is fit for purpose and in line with the direction provided.
Key Skills required to do the role
- Broad understanding of various aspects of RA and excellent knowledge of RA processes
- Strong Project management skills
- Strong organisation and problem solving skills
- Self-motivated, driven with a positive attitude
- Excellent communication skills
- Strong customer focus