Match score not available

Regulatory Affairs Manager EU and US Remote

Remote: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 
Arizona (USA), United States

Offer summary

Key responsabilities:

  • Partner with the Global Regulatory Lead and team.
  • Deliver and execute regulatory strategy for assets.
  • Co-lead GRST meetings to ensure quality decisions.
  • Track regulatory milestones and commitments.
  • Coordinate preparation of US submission components.
Hays logo
Hays Human Resources, Staffing & Recruiting Large http://www.haysplc.com/
5001 - 10000 Employees
See more Hays offers

Job description

Your New Company

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.

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.

#4605705 - Victoria Dunlop

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Human Resources, Staffing & Recruiting
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Analytical Thinking
  • Decision Making
  • Verbal Communication Skills

Regulatory Affairs Manager Related jobs