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Regulatory Clinical Application Associate

Job Description:

Hyper Recruitment Solutions (HRS) are currently looking for a Regulatory Clinical Application Associate to join a leading Regulatory Affairs Consultancy based in the Harlow, Essex area.

As the Regulatory Clinical Application Associate you will be responsible for


Your duties as the Regulatory Clinical Application Associate will be varied however the key duties and responsibilities are as follows:


You will prepare and submit clinical trial applications and substantial amendments to competent authorities and ethics committees throughout Europe, with an emphasis on UK & IE submissions.


As a Regulatory Associate you will prepare submissions using IRAS and EudraCT systems.


You will review and extract information from clinical trial associated documentation (incl.

IMPD's, IB's, EudraCT, Protocols & labelling), and write, review and implement SOPs/processes .


You will be responsible for Clinical Trial Management Plans & interaction with clients for CTA related activities.


To be successful in your application to this exciting opportunity as the Regulatory Clinical Application Associate we are looking to identify the following on your profile and past history:


Relevant degree in a scientific discipline.


Proven industry experience in the regulatory environment for Clinical Trial Applications, covering competent authority and ethics submissions.


A working knowledge and practical experience with the Regulatory IRAS system and HRA process for UK submissions.

Key Words: Regulatory Clinical trials application, Regulatory Affairs, biotech, pharmaceuticals, associate, submissions, protocols, labelling, Europe, ethics

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position.

HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science.

We look forward to helping you with your next career moves.