Regulatory Executive Senior
- Brentford, Greater London (GBR)
- £500 - £588.59 Per Day
- 12 Months
- Start date: ASAP
- Ref: GSK0JP00096567
- cmc
- pharmacy
- chemistry
Position: Senior Regulatory Executive
Location: Brentford
Pay Rate: £588.59 Per Day / Via Umbrella / Inside IR35
LOA: 12 Months
Job 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:
Degree in Pharmacy, Chemistry or related discipline.
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 Veeva Vault systems.
Demonstrated problem solving skills.
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.
Start date is flexible, but looking as close to July as possible
CMC RA experience is essential and this particular role will be predominantly global post approval variations.
Experience with Veeva Vault also helpful, but full training will be provided
