Chemical Clinical Pharmaceuticals
You will be required to be part of the preparation of high quality, post approval medicinal health care regulatory documents using varied information sources. liaising closely with other departments and 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.
- Medicinal healthcare regulatory 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 sites worldwide
- Be proficient in the use of IT packages such as Word and excel.
- Demonstrate problem solving skills
Role Specific Requirements
- Post Approval medicinal healthcare experience is a must
- Experience responding to authority requests and providing regulatory advice and strategies
- Experience working with global regulatory affairs
- Ability to manage multiple project assignments simultaneously and provide data assessment and conclusions
- Experience with labeling amendments and documentation
- Ability to efficiently interact with multiple and diverse departments
- Good communication skills and flexible approach – “ can do attitude”