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.
Back to searchRegulatory Affairs Manager EU and US Remote
Hays Specialist Recruitment Limited
Posted 6 days ago, valid for 11 days
Uxbridge, Buckinghamshire UB8 1DH, England
£60,000 - £72,000 per annum
Full Time
In order to submit this application, a Reed account will be created for you. As such, in addition to applying for this job, you will be signed up to all Reed’s services as part of the process. By submitting this application, you agree to Reed’s Terms and Conditions and acknowledge that your personal data will be transferred to Reed and processed by them in accordance with their Privacy Policy.
Sonic Summary
- The job is for a Regulatory Affairs Manager at a well-known biotech company, offering an 8-month contract with potential for extension.
- The role involves partnering with the Global Regulatory Lead and the Global Regulatory Sub-Team to execute regulatory strategies for assigned assets.
- Key responsibilities include co-leading meetings, tracking regulatory milestones, and preparing components for US submissions and FDA meetings.
- Candidates should have a minimum of 5 years of experience in regulatory affairs, particularly in the biotech or pharmaceutical industry.
- The salary for this position is competitive and commensurate with experience.
