location_onUxbridge, UK
watch_later Posted: Sep 15, 2024
Skills Required
Nice To Have skills
Job Description
Regulatory Affairs Manager – EU and US
This well-known biotech is looking for Regulatory Affairs support from an experienced contractor. This is an 8-month contract job with scope for extension.
Your new role
As Regulatory Affairs Manager, you will partner with the Global Regulatory Lead (GRL) and the wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s). You will co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions decisions; diligent follow-up with sub team members to uphold accountabilities and drive decision making and develop and maintain the asset’s global regulatory book of work and Global Submission Plan.
You will track key regulatory milestones as defined by the GRST, health authority meetings, post-approval commitments, annual reports, etc.
As Regulatory Affairs Manager, you will co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents, as well as support and co-ordinating preparations for FDA meetings.You will track key regulatory milestones as defined by the GRST, health authority meetings, post-approval commitments, annual reports, etc.
What you need to do now
For more information on this or any other Regulatory Affairs contract jobs, please apply to this advert.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.