Contract-to-Hire Regulatory Operations Manager - 100% Remote
6 Month Contract-to-Hire
My client is a midsize pharmaceutical company focused on innovative treatments for oncology. This growing pharmaceutical company with multiple products in the commercial phase is looking to expand their regulatory operations team by adding a Manager of Regulatory Operations.
The Regulatory Operations Manager will be responsible for:
- Facilitating eCTD/CTD publishing services such as bookmarking, rendering, hyperlinking, creating Table of Contents
- QC Regulatory submissions to Regulatory Agencies
- Correspondence with Health Authorities
- Drafting and reviewing SOPs related to submission preparation
- Adhering to and monitoring regulations and guidelines set by Global Health Authorities
The Regulatory Operations Manager should have the following qualifications:
- 5+ years of regulatory submissions experience
- Experience with eTMF systems
- A strong publishing background
- A strong submissions background
If you are interested in the Regulatory Operations Manager position, then please don't wait to apply!