Regulatory Affairs Manager - UK and Ireland
Your new company
This well known biopharma is looking for an experienced Regulatory Affairs Manager to join their established UK and Ire team. This is a 12-month contract job with scope for extension and offers hybrid working
Your new role
This is an affiliate Regulatory Affairs role. The Regulatory Affairs Manager will assist in 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.
The core elements of this pivotal role will include supporting local execution of the EU regional regulatory strategy, including clinical trial application (CTA) submissions and of the UK and Ireland affiliate commercial strategy, with a focus on Oncology and Acute Anti-infections.
Specific Job Requirements
- Expert on regulatory environment and intelligence within the UK and Ireland and contributes to preparation of new local regulatory guidance documents when applicable.
Management of initial Marketing Authorisation (MA) applications, Variations, and other MA maintenance applications.
- Timely and compliant filing of clinical trial applications, amendments, and other clinical trial submissions.
What you'll need to succeed
In order to be considered for this 12-month contract job as Regulatory Affairs Manager UK and Ire, you should have Regulatory Affairs experience gained in an affiliate or global role and be experienced in the management of CTAs including amendments and other CT related submissions.
What you'll get in return
Flexible working options are available. Hybrid working pattern
What you need to do now
For more information about this or any other Regulatory Affairs contract jobs, please apply for this advert.