Senior Regulatory Executive: CMC
- Preparation of high quality, Chemistry ,manufacturing and control (CMC) detailed regulatory documents using varied information sources
- Liaising closely with other GSK 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 GSK sites worldwide.
- Be proficient in the use of IT packages such as Word and excel.
- Demonstrate problem solving skills
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world. For more information on GSK please refer to our website: www.gsk.com
GSK’s Worldwide Real Estate and Facilities (WREF) deliver the right space in the right location, and at the right cost, with industry competitive and customer focused services. The organisation oversees and operates circa 16 million square feet of space with a population of over 28,000 GSK and other staff, including all pharmaceutical and consumer health R&D laboratories and pilot plants, as well as commercial office accommodation for all GSK business units. This portfolio of property currently requires an annual spend of more than £450m in operating costs and £200m in capital investment.