Regulatory Submissions Manager – South East, UK

Regulatory Submissions Manager required for a leading healthcare pharmaceutical company based in the South East, UK.

Our client is a leading healthcare pharmaceutical company, who specialise in the discovery and development of innovative therapies that contribute to the health and well-being of people the world over. This multinational pharmaceutical organization are currently looking for a Regulatory Submissions Manager to join their Regulatory Affairs team based in the South East of England.

Reporting to the Senior Manager, Global Regulatory Operations,  as Regulatory Submissions Manager, you will be responsible for developing the submission timelines with the team leader and eDocumentatin representative. You will be required to collect status updates from members of other teams and informing the Project manager of these activities. You will also be responsible training new members of staff on the submission process.

Further key tasks involved with this Regulatory Submissions Manager job will include:

  • Arranging the submission team meetings.
  • Developing agenda items by working alongside the RA team leader.
  • Facilitating EU RA meetings to manage eCTD marketed product lifecycle.
  • Liaising with other team members regarding strategies and targets.
  • Developing the submission timeline.
  • Maintaining regulatory submissions calendar.

The successful candidate for this Regulatory Submissions Manager job will have a sound knowledge of regulatory submissions/ePublishing, as well as the ability to ensure that submissions adhere to internal SOPs. Further competencies required for this job include:

  • Excellent communication skills to interact with colleagues.
  • Good problem solving skills.
  • Project management experience.

This is an excellent opportunity for the right candidate to develop their career within Regulatory Affairs within a fast paced and nurturing pharmaceutical company which operates on a global basis.

If you would like to hear more about this Regulatory Submissions Manager job, please contact Meera Pattni on 01438 743037 or email mpattni@ckclinical.co.uk.

Alternatively, apply for this Regulatory Submissions Manager online now.

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