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Regulatory Affairs Manager - CTA

HertfordshirePermanent
Experience Dependant
Job Reference: J5631848
Updated On: 13/08/2019
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Consultancy

Skills: Regulatory Affairs - UK, Regulatory Affairs - Clinical, Regulatory Affairs - Manager / Director / Executive, Clinical - Clinical Operatoins Manager

Job Information

Role Overview

We are currently looking for a Regulatory Affairs Manager with experience of Clinical Trial Applications to join a leading Regulatory Consultancy based in the Hertfordshire area. As the Regulatory Affairs Manager - Clinical Trial Applications you will manage a small team focused on providing support for Clinical Trial Applications and amendments during studies conducted in the UK and Ireland.

Key Duties and Responsibilities

Your duties as the Regulatory Affairs Manager - CTA will be varied however the key duties and responsibilities are as follows:

1. Line manage a small team of consultants and assist with the development and training of Junior employees.

2. Act as Project lead for assigned clients and coordinate the preparation of Clinical Trial Applications (CTAs) and substantial amendments.

3. Prepare, review and coordinate CTAs, ARSAC submissions and responses to questions.

4. Maintain internal standards and processes including Clinical Trail Management Plans

Role Requirements

To be successful in your application to this exciting opportunity as the Regulatory Affairs Manager - CTA we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline (e.g. Biology, Chemistry, Clinical Studies etc.) in addition to hands on experience of the writing and submission of Clinical Trial Applications.

2. Proven industry experience of working in a Regulatory environment with a focus on Clinical Trials

3. A working knowledge of EU regulations for clinical trials exposure to submissions and regulatory approvals.

Key Words: Regulatory Affairs | Clinical Trails | Clinical Trial Application | CTA | Submissions | Substantial Amendments | EU Regulations | IRAS Forms | ARSAC submissions
Georgia Walden
Your Recruitment ConsultantGeorgia WaldenGeorgia.walden@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We 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 recruitment processionals and scientists. We look forward to helping you with your next career moves.