Offer summary
Qualifications:
Undergraduate degree in scientific field required, 7+ years’ experience in regulatory affairs, Direct writing experience for global applications, Experience with Radiopharmaceuticals preferred, Comprehensive knowledge of drug development.
Key responsabilities:
- Prepare and execute global regulatory strategies
- Provide regulatory guidance as subject matter expert
- Lead interactions with regulatory agencies
- Consolidate information for regulatory submissions
- Monitor health authority regulations and compliance