Regulatory Executive - CMC
A large global pharmaceutical company with leading products across various therapeutic areas are looking to hire a Regulatory Executive - CMC at their Stockley Park office in Hertfordshire, UK. This vacancy is an exciting opportunity to work at a top 10 global pharmaceutical company that employs approximately 100,000 people worldwide.
The job details are:
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 personnel to ensure accuracy of such records. Work to agreed deadlines, with ability to respond readily to changing events and priorities.
- CMC Regulatory experience with awareness of the global CMC requirements for clinical trials documents and marketing authorisation applications.
- Good written and oral communication.
- Demonstrated ability to focus, work with attention to detail and retain critical information.
- Demonstrated team working and effective time management skills.
- Able to establish strong relationships and liaise effectively with GSK sites worldwide.
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.
Global marketing applications for new medicines and managing the related responses to questions, including EU, US, Japan and emerging markets
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Peter Duvall on 0203 0789 542 or upload your CV on our website www.proclinical.com. A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.