Regulatory Affairs Associate

Location: Slough, England, United Kingdom
Salary: No information
Job Type: Permanent
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Real Staffing have exclusively partnered with a global pharmaceutical company that is a market leader in their area of specialty.

Due to an increase in work demand, our client is currently in need of a Permanent Regulatory Affairs Associate to join their team.

The role will be reporting to the Regulatory Affairs Manager and initially be based in the office.

Job Purpose:

To take responsibility for and execute various regulatory activities in the EMEA region.

The ideal post-holder will need:

  • Preparation and maintenance of the product information (SmPC/PIL).
  • Maintenance of a regulatory archive (dossiers, documents, electronic media).
  • Preparation, submission and management of variation applications to agreed timelines.
  • Preparation of regular reports for regulatory and management purposes.
  • Manage and submit Variations, Renewals and PSURs in line with specified timelines.

Requirements:

  • Experience (2 +years) in RA
  • Good understanding and experience of EU regulatory requirements including marketing authorisation submissions and maintenance activities on a European level.
  • Experience working in a UK affiliate is a requirement.
  • Ability to work to deadlines and able to successfully prioritise numerous projects simultaneously.

Please use a cover letter to highlight how you meet the criteria for the role (highlighting your experience)Your cover letter along with your CV will be used to assess your application.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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