Minimum of 4-year undergraduate degree
5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry
Understanding of GxP systems and Quality principles
Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies
Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications