- The Senior Regulatory Affairs Specialist will be responsible for registration document(s) procurement, preparation, coordination submission and archival
- You will coordinate legalization and delivery of registration documents following the instructions provided in the request.
- The Senior Regulatory Affairs Specialist will maintain tracking and organization of documentation, including uploading in CSD tool or other document repository.
- Supports the Site Regulatory CMC Team in the compilation and preparation of marketing application and post-approval submissions as needed.
- Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.
The next Senior Regulatory Affairs Specialist should have a Bachelor/Master’s degree (Regulatory, Life Sciences, Biotechnology or related discipline)
You should also have a basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS)
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.