Freelance Associate Director Regulatory Writer
My client is a clinical stage NASADQ listed global Biopharma are developing products, which will make a difference to patients suffering from rare diseases globally.
I have been assigned to search for a Freelance Associate Director Regulatory Writer to be based remotely on the East Coast of the USA. The role is to support the development of a BLA module 1 and 2.
Responsibilities
Writing and development of BLA Module 1 and Module 2
Drafting responses to FDA including regulatory and clinical aspects
Role Requirements
Minimum 5 years within regulatory affairs for sponsor companies
Minium 3 years in regulatory and clinical writing
Understanding of ICH GCP, FDA regulations and compliance
This is a prime opportunity to work on some of their most fascinating product’s date. If you are interested, please send your CV to nathan.mcgovern@scientasearch.com for further information.