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Regulatory Affairs Manager EU and US Remote

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

United Kingdom

Offer summary

Key responsabilities:

Partner with Global Regulatory Lead for strategy.
Co-lead GRST meetings for quality discussions.
Track regulatory milestones and commitments.
Coordinate preparation of US submissions.
Support FDA meetings preparations.

Lifelancer Information Technology & Services Startup https://lifelancer.com/

11 - 50 Employees

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Job description

Regulatory 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 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 assets 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 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.

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

https://lifelancer.com/jobs/view/e293693e40d14f0c74227dcbe79a439d