As a Regulatory Writer, you will play a key role in this expanding team of Regulatory Authors based in Yorkshire, UK.
Our Client is a leading Healthcare and Pharmaceutical provider who consistently features in the top 100 places to work. You will join an expanding team of Module 3 authors to write and produce material for submission as part of Regulatory Excellence projects.
Other responsibilities of this Regulatory Writer position will include:
- Work collaboratively with other members of the Regulatory team and other personnel in R&D teams to provide documentation for existing products.
- Take existing documentation and reformat, modifying as required, in the eCTD format.
- Gather existing documentation from R&D teams
- Identify gaps in documentation then obtain information/documents etc to plug the gaps.
- Where licence variations are submitted without a full Module 3 provide appropriate analytical & formulation documentation to support the variations.
- Assist in the preparation of responses to questions arising from the submission of any documents prepared.
For more information about this Regulatory Writer role or others we are handling please contact our regulatory recruitment team on 01438 743047 or email Jonathan (email@example.com or Meera (firstname.lastname@example.org).
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