Regulatory Executive Senior
- Ware, ENG (GBR)
- £65 - £65 Per Hour
- 6 Months
- Start date: 11 Feb 19
- Ref: GSK0JP00075509
- Pharma - Regulatory Affairs
- pharmaceutical submissions
- managing projects
- marketing
- microsoft office (inc Office365)
- manufacturing
- clinical trials
- Biotechnilogie
- regulatory documents
- documentum
- emerging markets
- cmc
Description:
Preparation of high quality chemistry, manufacturing and control (CMC) regulatory documents for new, small molecule products, using varied information sources and liaising closely with other GSK personnel to ensure accuracy of such records. Work to agreed deadlines, with ability to respond readily to changing events and priorities.
Required Skills:
CMC Regulatory Affairs experience; planning, authoring, reviewing and project management of regulatory submissions.
Good written and oral communication. Demonstrated ability to focus, work with attention to detail and retain critical information.
Demonstrated team working skills, with the ability to establish strong relationships and liaise effectively with GSK sites worldwide. Demonstrated effective time management skills.
Be proficient in the use of IT packages such as Word, Excel and Documentum systems.
Demonstrated problem solving skills.
Degree in Pharmacy, Chemistry or related discipline.
Preferred experience:
Global experience, (including EU, US, Japan and emerging markets), in the following types of CMC submissions:
Clinical trials documents
Marketing applications for new medicines and managing the related responses to questions.
Post approval variations.
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.
