Your new company
I am currently collaborating with a leading Regulatory consultancy company who are looking to appoint a Clinical Trials Application Senior Associate who will take the lead on managing Clinical Trial Activities.
Your new role
As the Senior Regulatory Affairs Associate you will be responsible for preparing and submitting clinical trial applications and substantial amendments to competent authorities and ethics committees throughout Europe, you will prepare submissions using IRAS and EudraCT systems, review and extract information from clinical trial associated documentation (incl. IMPD’s, IB’s, EudraCT, Protocols & labelling), write, review and implement SOPs/processes and liase with clients when required.
What you'll need to succeed
To be successful in securing this job, you should have:
-A degree in a Scientific discipline (or equivalent)
-Demonstrated clinical trial experience, covering competent authority and ethics submissions
-Experience with IRAS system and HRA process for UK submissions
-Strong understanding of the regulatory environment for Clinical Trial Applications
Ability to work under pressure and achieve timely submission and regulatory approvals
-Good computer skills
What you need to do now
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 on your career.
- Job Type:
- Life Sciences
- Up to £48,000 dependant on experience
Similar jobs to Regulatory Affairs Senior Associate (CTA)
Senior manager, regulatory affairs, london, eu.
£60,000 - £72,000
Regulatory affairs manager respiratory
35000 - 45000
Regulatory affairs officer AND new submissions AND CMC AND EU
25000 - 35000
Regulatory affairs manager AND generic medicines AND CMC AND new submissions AND EU
£35,000 - £45,000
Regulatory affairs officer maidenhead EU UK
£25,000 - £32,000
Excellent job opportunity for an Audit & Accounts Senior with progression to management in 12 - 18 months.
£30000 - £40000 + excellent benefits (DOE)sponsored