Insight Global is looking for a CMC Regulatory Consultant to join the team of a large pharmaceutical company within their animal health products division. This consultant will be supporting global regulatory projects related to drug substances and drug products. This individual will be owning the MCSR (Minor Changes and Stability Report) process for finished products and APIs. They will also support the API supplier change project with reviewing and assessing CMC change controls followed by authoring impacted CMC documents. The ideal candidate will have a strong background in regulatory affairs within the pharmaceutical industry along with project management and technical writing skills.
- 4+ years experience in Regulatory Affairs within the pharmaceutical industry
- Experience assessing CMC change controls
- Experience authoring CMC sections
- Project Management Skills
- Technical Writing Skills
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.