Knowledge, Skills & Competencies:

•             Strong authoring skills of documentation and Health Authority responses

•             Ability to resolve strategic technical and regulatory issues

•             Should demonstrate initiative, analytical thinking and works independently

•             Ability to work well with cross functional teams, and good communication skills with internal and external stakeholders

•             Experience working with a Health Authority is helpful but not essential

•             Knowledge of global regulations/guidelines, key Health Authority/Industry Guidance and trends are helpful

 

Qualifications:

Education / Experience

•             Bachelor’s degree in Biological Sciences with 2+ years Regulatory Affairs experience OR Master’s degree in Regulatory Affairs/Quality Assurance or an appropriate combination of other relevant industry experience e.g., Quality and/or Manufacturing

•             Requires knowledge and understanding of CMC topics, as well as North American, European and International regulations/guidelines  

•             Ability to manage multiple priorities efficiently

•             Experience working on Project teams

•             Demonstrated knowledge of microbiology, immunology, virology or bacteriology

•             Excellent skills in communication, writing and teamwork