Overview

Reference Number: JO-2112-481554
Regulatory Affairs Manager
Rate: Negotiable
Job Type: Contract
Location: City

Regulatory Affairs Manager

Initial 6 month contract

Remote Based

Offering up to 65.00 Per Hour

CPL Life Sciences is privileged to working with an international pharmaceutical firm who have an urgent requirement within their Virology team. Working as a Regulatory Affairs Manager on an initial 6 month contract you will be supporting the team the Hepatitis B portfolio supporting Post Approval and Centralised Procedure activities.

Job Responsibilities include;

For approved medicinal products, co-ordinate the submission of non-clinical, clinical and safety regulatory documentation via the European Centralised procedure, e.g. Type I and Type II variations, line extension applications, responses to questions, renewals, PSURs etc.

For investigational medicinal products, co-ordinate the submission of applications to support early phase development, including Clinical Trial Applications.

Participate and contribute to regulatory team meetings.

Use internal electronic systems for planning, preparing, tracking and storing submissions to regulatory agencies.

Candidate Requirements include;

Eligibility to live and work in the United Kingdom

Life Sciences degree or equivalent

Experience in EU Regulatory Affairs and the centralised procedure, in particular for post-approval activities.

Availability to start in January 2022

If this position is of interest to you please forward your up to date CV to Sophie on sophie.malyon@cpl.com.

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