Regulatory Affairs Manager

  • Department: Regulatory Affairs
  • Location: Harlow, Essex
  • Education Level:
  • Employment Type Level: Full Time
  • End Date: 24-Apr-2017

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Overview

Are you experienced within Regulatory Affairs? Do you have knowledge in food supplements, vitamins or other non-medicinal products? If so then we’re looking for someone like you… 

Teva currently have a full time position in the Central OTC RA team to support all registration activities for Non-Medicinal products, including food supplements, medical devices, vitamins, health food, human and traditional medicinal products, and cosmetics.

You will work as a key Regulatory Expert within Teva’s busy Regulatory Affairs department. Over 200 people, across multiple functions are based in Harlow, 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

  • Closely collaborate with Medical, Pharmacovigilance and Quality functional groups.
  • Medicine/Veterinary/Sciences/ Science degree or equivalent in terms of industrial experience.
  • Experience in registration of Non-Medicinal products in the EU and/or other international markets, with focus on food/food supplements
  • Regulatory experience with Medical Devices is highly desirable
  • Understanding of regulatory affairs and the pharmaceutical environment
  • Understanding of regulatory procedures and requirements for food/food supplements
  • Understanding of pharmaceutical development and life cycle management

Main Responsibilities

  • Perform the necessary regulatory tasks to support the registration process for non-medicinal products in collaboration with regional and local RA units.
  • Ensure high quality data and standards are used in support of all regulatory applications to achieve rapid and successful assessment.
  • Co-ordinate the preparation and conduct the review of responses to questions raised by the regulatory authority/ies.
  • Provide regulatory support to project teams, stakeholders and customers, as required.
  • Ensure maintenance of all marketed products in compliance with national regulatory requirements.
  • Work with your line manager to develop and implement regulatory strategies that enable the delivery of a pipeline of product innovation to meet regulatory requirements.
  • Work with your line manager to prepare, compile, review and submit appropriate high quality regulatory dossiers and responses to Health Authority questions in accordance with in-house standards and current legislation.
  • Prepare and manage changes to product registrations and responses to queries from Regulatory authorities
  • Keep the RA manager up to date on regulatory trends, risks and opportunities for the business.