As Senior 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 coordinate the activities of the rest of the team of Module 3 authors as well as provide material yourself for Regulatory Excellence projects.
Key responsibilities of this Senior 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 license 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, or to apply for this Senior Regulatory Writer position, please contact our regulatory recruitment team on 01438 743047 or email Jonathan (firstname.lastname@example.org) or Meera (email@example.com).