The RoleTo prepare high quality CMC detailed regulatory documents using varied information sources. liaising closely with other company personnel to ensure accuracy of such records....
To prepare high quality CMC detailed regulatory documents using varied information sources. liaising closely with other company personnel to ensure accuracy of such records.
- Work to agreed deadlines and maintaining records to reflecting project status.
- Hands on technical experience in authoring CMC dossiers
- Taking on the project lead, manufacturing changes and post approval
- 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 pursue 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
- Be proficient in the use of IT packages such as Word and excel.
- Demonstrate problem solving skills
Minimum degree level, in any life sciences.
Working experience within Regulatory Affairs/CMC.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.