Regulatory Affairs Manager EU and US Remote - Hays Specialist Recruitment Limited : Job Details

Your new companyRegulatory Affairs Manager - EU and USThis 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 roleAs 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.What you need to do nowFor 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.