Regulatory Affairs Officer
Based in Hertfordshire, my client manufactures a wide range of plasma-derived therapeutic products which are distributed to over 40 countries worldwide. They are committed to supporting both healthcare professionals and providing a continuous supply of reliable, high quality, life saving products to patients on a 24/7, 365 day a year basis, and have a vibrant 60-year heritage and is currently embarking on an ambitious programme of investment in research, technology and manufacturing methods to grow the business significantly over the next few years.
They are currently recruiting for a number of positions and are interested specfically in receiving applications from qualified regulatory affairs officers with the following skills;
+ Min of 3 years experience in a Regulatory Affairs function
+ Solid experience with licencing activities in Middle East countries, South America and Asia.
+ Knowledge of generation and maintenance of Company Core Safety Information (CCSI)
+ Experience with the end-to-end procedure for generation of drug labels and maintaining compliant drug labels in the UK and "rest of world markets"
+ Experience of dealing directly with Health Authority assessors, in particular the MHRA.
+ Demonstrated effective communication and collaboration with agents and distributors in "rest of the world "countries.
+ Knowledge of current legislation and guidance related to labelling of medicinal products.
+ Knowledge or experience of generating eCTD documentation packages, in particular Module 1
Salaries are dependent on experience.