Senior Regulatory Affairs Officer/Associate

Austin Fraser are currently recruiting a Regulatory Affairs consultant for a new 6 month contract opportunity based in Berkshire.

My client are looking for an experienced contractor, with sufficient Regulatory Affairs experience to be comfortable assuming the responsibilities of Senior RA Officer/Associate.

The proposed work will involve:

Gaining regulatory authority for new clinical trials
Gaining marketing authorisations for new pharmaceutical products.
Maintaining marketing authorisation.
Liaising with external regulatory authorities.
Maintaining awareness of current and new legislation/guidance and ensuring that work is in compliance with the statutory requirements.
Managing regulatory projects and interacting with other departments.

My client are particularly keen to bring in a contractor with strong marketing/post-marketing and commercial experience. Any exposure to the drafting of packaging text, SmPC's and PIL's is highly desirable.

If this position is of interest and you would like to discuss in more detail, please either submit your CV in response or alternatively, call directly on the number provided.