Description
Regulatory Executive Senior (Labelling, CMC, Immuno/Inflammation)
Description:
Are you looking for a Regulatory Executive Senior role or aspire to be one?
Do you want a role which will allow you to contribute positively to not only your community but the world?
Come and join us! Together we can serve the patients around the world to do more, feel better and live longer!
Who are we?
At GSK we are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. Our mission is inspiring and challenging - to help people do more, feel better and live longer.
We have a significant global presence with commercial operations in more than 150 countries, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium and China.
Responsibilities:
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 the 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
Additional information about the process
All profiles will be reviewed against the required skills and experience. Due to the high number of applications, we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply.