The Role
The Regulatory Affairs Associate is responsible for the following;
1. Keep abreast of current regulations in the compliant movement of pharmaceutical products
2. Communicate and liaise with regulatory agencies as needed to support the development of the regulatory database of country-specific information
3. Support in the growth of the regulatory database of country-specific information
4. Creation of country summaries, carrying out country-specific research as needed
5. Keep up to date with regulatory changes towards the procurement, movement, and distribution of unlicensed medicines
6. Provide regulatory support to the project management team.
You
To apply for this role as Regulatory Affairs Associate our client is hoping for someone with the following skills and experience
7. Previous Regulatory affairs experience within clinical trials submissions
8. Early phase 1-3 clinical trial experience
9. Basic knowledge of GMP and GDP and MHRA Guidance Note 14
10. Knowledge of or experience with expanded access programs, compassionate use, named patient programs, unlicensed medicines is highly desirable although not essential
11. Experience liaising with the relevant health authorities across the UK/EU
12. Life sciences degree