Description
Position: CMC Regulatory Affairs Team Lead
Location: Ware, Hertfordshire.
Start Date: ASAP
Rate: Excellent Rate per hour
Description:
- Preparation of high quality, Chemistry, manufacturing and control (CMC) detailed regulatory documents using varied information sources.
- Liaising closely with other personnel to ensure accuracy of such records.
- Working to agreed deadlines and maintaining records to reflecting project status. responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving.
- Proactively pursuing process improvement and sharing of best practice.
Required Skills:
- CMC experience: good written and oral communication and networking skills.
- Demonstrate ability to focus and work with attention to detail.
- Demonstrate ability to retain critical information.
- Be aware of the contents of a marketing authorization application. Demonstrate team working and effective time management skills.
- Be a dynamic and highly motivated individual Establish strong relationships and liaise effectively with company sites worldwide.
- Be proficient in the use of IT packages such as Word and excel.
- Demonstrate problem solving skills