Senior Regulatory Affairs Manager

  • Department: Regulatory Affairs
  • Location: Harlow, Essex
  • Education Level:
  • Employment Type Level: Full Time
  • End Date: 29-May-2017

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Overview

Do you have a strong eye for detail coupled with an analytical mind, with experience in the pharmaceutical industry and Regulatory Affairs? You might be just what we’re looking for…

Your previous experience in the pharmaceutical industry will help you in supporting the OTC RA team in with pre-market RA activities from assessment, strategies, compilation, submission, outcome delivery and overall guidance for OTC medicinal products.  Along with managing a high performing team you will also deputise for the AD of PGT Regulatory Affairs when required, making this a role where you will use your leadership, relationship and technical skills in driving the department forwards for 2017 and beyond.

Based at our Harlow office, Essex you will join a large team of Regulatory Affairs professionals, working in a key hub of Teva’s Regulatory function. Here at Harlow there are over 200 people working across multiple functions, working collaboratively for Teva, one of the biggest pharmaceutical companies in the UK and among the top 15 pharmaceutical companies in the world. 

Skills & Experience

  • Degree in Life Sciences or similar
  • Good knowledge of pharmaceutical & scientific processes
  • Significant experience within EU Regulatory Affairs
  • Specific experience in registration of OTC products in the EU and other international markets
  • Knowledge in registration process and assessment of OTC human medicinal products
  • Line management or Supervisory experience
  • Project management experience would be useful

Main Responsibilities

  • Lead the registration process for new Marketing Authorisation Applications
  • Provide initial and final regulatory strategies in accordance with COREx processes
  • Contribute to strategic decisions requiring regulatory input to minimise risks
  • Lead the maintenance work on launch critical post-approval variations for authorised products
  • Provide central RA support to countries and regions
  • Provide RA support to new initiatives
  • Identify needs for new SOPs / WIs to improve processes

Job Description

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