Regulatory Affairs Manager EU and USThis wellknown biotech is looking for Regulatory Affairs support from an experienced contractor.
This is an 8month 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 SubTeam (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s).
You will colead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions decisions; diligent followup with sub team members to uphold accountabilities and drive decision making and develop and maintain the assets global regulatory book of work and Global Submission Plan.
You will track key regulatory milestones as defined by the GRST health authority meetings postapproval commitments annual reports etc.
As Regulatory Affairs Manager you will coordinate preparation of regulatory components for US submissions and author assigned m1 documents as well as support and coordinating preparations for FDA meetings.
What you need to do now
For more information on this or any other Regulatory Affairs contract jobs please apply to this advert.
If youre interested in this role click apply now to forward an uptodate copy of your CV or call us now.
If this job isnt quite right for you but you are looking for a new position please contact us for a confidential discussion about your career.
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