Senior Regulatory Affairs Officer – Yorkshire

Shreeya Patel at CK Clinical is currently recruiting for a Senior Regulatory Affairs Officer to join a pharmaceutical company at its site in Yorkshire

Responsibilities:

As a Senior Regulatory Affairs Officer you will report to the Principal Regulatory Affairs Officer ans have the following responsibilities:

  • Collate documents and prepare marketing authorisation applications.
  • Prepare packaging in line with EU regulatory guidelines, submissions to external databases and liaising with user test teams.
  • Preparation of type I and II variations.
  • Assessment of PSUR data.
  • Licence preparation, national, MRP and DCP.
  • Prepare, review and submit CTAs.

Qualifications and skills:

The successful candidate for this Senior Regulatory Affairs Officer must have the following skills:

  • Prior experience within regulatory affairs required.
  • Knowledge of CTAs and MAAs.
  • Ability to prioritise workload.
  • Problem solving ability.
  • Attention to detail.

Benefits:

This Senior Regulatory Affairs Officer role will include the following benefits:

  • Bonus scheme
  • Incentive scheme
  • Discounted gym

How to apply:

For more information or to apply for this Senior Regulatory Affairs Officer role, please contact Shreeya Patel on 01438 743 047 or email spatel@ckclinical.co.uk. Please quote reference CL24273 in all correspondence.

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