Overview
Reference Number: JO-2206-496044
Regulatory Affairs Officer
Rate: Negotiable
Job Type: Permanent
Location: Elstree, Borehamwood
Regulatory Affairs Officer
Elstree Hertfordshire Hybrid
Up to 47,000
Regulatory Affairs Officer opportunity working for a rare disease biotech based in Hertfordshire. The business works across immunology, critical care, and Coagulation Disorders and are looking for a Regulatory Officer to support its regulatory team.
As a Regulatory Affairs Officer, you will assist the Regulatory Affairs Team in obtaining and maintaining Marketing Authorisations worldwide.
Responsibilities
Prepare and submit license applications with the aim to gain new drug licenses, maintain existing licenses, and get permission to start a clinical trial in line with country-specific regulations.
Intercontinental markets (ie AMEA/ ASIA, LATAM markets) Previous UK market experience would be desirable/ RoW markets.
Post- Approval, lifecycle maintenance, variations (type 1a, 1b, and type 2), renewals, and license changes.
Requirements
Bachelors degree or higher in Life Sciences or technical field and around 2 years of experience in pharmaceuticals or a related industry.Advanced degree preferred.
Experience working with intercontinental markets.
This opportunity allows for great career progression opportunities as well as the opportunity to work remotely with the occasional meeting in the office-based in Hertfordshire. The role also includes a 10% bonus, private health insurance, pension, life insurance, and 25 days holiday.
If you are interested in this role or would like more details please email your CV to lucy.kirkaldy@cpl.com
