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.
Please apply now!