Offer summary
Qualifications:
BA/BS in Life Science/Health related degree, Minimum of 3 years in Regulatory Affairs/Operations, Knowledge of global regulatory guidelines, Experience with IND/IMPD/NDA/MAAs submission, Hematology and oncology experience preferred.
Key responsabilities:
- Coordinate regulatory submissions to health authorities
- Provide support to clinical study teams
- Manage regulatory operations function and vendors
- Maintain expert knowledge of regional regulations
- Interface with Regulatory Leads on project priorities