Job Summary
A staffing company is in need of a Remote Regulatory Affairs Manager III.
Must be able to:
- Develop and deliver innovative, breakthrough global regulatory strategies
- Develop and execute integrated global regulatory strategies
- Provide regulatory support for various departments, projects, and teams
Applicants must meet the following qualifications:
- Represent the company with domestic and international regulatory authorities and partners
- 8 years pharmaceutical/biotechnology industry experience with technical management experience
- Minimum of 6 years in Regulatory Affairs
- Experience in interpretation of regulations, guidelines, policy statements, etc
- Experience in the preparation of major regulatory submissions and supportive amendments or supplements
- Extensive experience working on products in development