Regulatory Affairs Manager - contract job - UK and Ireland - remote working
Your new company
This well-known biotech is looking for a Regulatory Affairs Manager to join their established Uk and Ireland team. This is a 12-month contract job with scope for extension.
Your new role
The Regulatory Affairs Manager will be responsible for the local coordination and execution of regulatory submissions in compliance with corporate standards and national regulatory requirements, and of Regulatory Affairs processes and deliverables for the UK and Ireland.
Reporting to the Regulatory Director for the UK and Ireland, the core elements of this pivotal role will be to support and execute local and EU regulatory strategy, including the management of marketing authorisations, clinical trial application (CTA) submissions and regulatory support for the UK and Ireland affiliate commercial activities.
What you'll need to succeed
In order to be considered for this contract job as Regulatory Affairs Manager, you must have experience in/knowledge of developing and maintaining CTA documentation in the EU (e.g. IMPDs, IMPD amendments) and the ability to work with some autonomy. I am looking for Regulatory Affairs Managers who are experienced in the review of promotional and non-promotional material in accordance with the UK and Irish industry codes of practice.
What you'll get in return
Flexible working options are available. Mostly remote, with twice per month in the office
What you need to do now
For more information on this or any other contract jobs in Regulatory Affairs, please apply for this advert.