We have a new position within our Regulatory team to fill with a specific skills set and wondered whether you could help. It is a contract position for a 0.5 headcount (preferably over 5 days but is flexible), from August 2012 onwards for about 12 months.
The primary responsibilities include:
Delivery of the European SmPC via leadership of the “client” labelling working group members in progressing the SmPC throughout the approval procedure
Strategic regulatory support to presentation of data and key messages
Direct liaison with “client” EU Regulatory and “client” Commercial as necessary
Oversight of PIL and all artwork mock ups including preparation in liaison “client”
Oversight and review of PIQ & QRD and labelling responses and labelling meetings
Attendance at internal “client” meeting & “agency” meetings as required
Provide internal labelling training to Regulatory team members
The position we are looking to recruit must be assertive and have a get up and go attitude.