Description
A leading Pharmaceutical Manufacturer is seeking an experienced Regulatory Affairs Consultant, to join their manufacturing campus in Essex.The main accountabilities of this role are:
. Responsible for CMC related regulatory activities for assigned projects.
. Creating and completing dossiers without assistance.
. Life Cycle management for licensed products, in the UK.
. Updating SPC (Summary of Product Characteristics) and ensure that these are all to standard.
. Updating PIL (Patient Information Leaflet) and ensure any amendments that arise are incorporated.
Experience required:
. Degree in Pharmacy is an advantage.
. Experience in Regulatory Affairs (RA) with knowledge of UK & European regulatory procedures and requirements for manufacturing registration.
. Proven strong oral and written English communication skills.
. Demonstrated ability to work and draft technical documents in a fast paced environment.
. Strong attention to detail.
This is a fantastic opportunity to join a Pharmaceutical Manufacturing Company.