Overview of Your Role
As a Regulatory Affairs Officer, you will support the teams with regulatory submissions in UK & Europe. The role will be supporting other members of the team with submissions, authoring, editing and coordinating documents for UK and European clients. This graduate role will include both internal and external training.
Collect and / or create country specific documents for regulatory filings
Compile and maintain documentation
Ensure compliance via timely submissions to regulatory agencies
Support process improvement initiatives, standards development, and metrics.
Understand role of publishing and application to regulatory affairs
Creation of eCTD sequences Your Key Skills, Experience & Attributes
You must be a recent BSc graduate in a life science or related biological subject
Committed to delivering to deadlines within a team environment but also working independently
Excellent interpersonal skills, competent written and oral communicator
Able to work collaboratively with colleagues based in different offices and in the longer-term clients in UK, Europe and ROW.
Proficiency with MS office and Adobe Acrobat
Able to learn new software and processes
Organised with a strong attention to detail and time management skills
Able to adapt as relevant regulations continually evolve
Troubleshooting issues with systems or documents Desirable Skills
Interest in medical/pharmaceutical developments, a basic understanding of medical terminology would be helpful.
Familiarity of document management systems would be an advantage. Salary / Perks / Benefits
Competitive salary with a profit-related bonus and 30 days holiday including bank holidays.
Internal and external training will be provided and opportunities will be available to develop your career within regulatory affairs.
This a permanent, full time office based position, 37.5 hours per week.
Interested? Apply today