Regulatory Affairs Strategy Manager (Oncology)
Exelixis(2 months ago)
About this role
This role involves managing and maintaining regulatory submissions including Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics Licensing Application (BLA) in compliance with guidelines and regulations. The position requires coordination and tracking of product applications and submissions, assisting senior regulatory leaders, and responding to information requests from regulatory bodies.
Required Skills
- Regulatory Submissions
- IND
- NDA
- BLA
- Compliance
Qualifications
- Bachelor's Degree in Related Discipline
- Master's Degree in Related Discipline
- PhD in Related Discipline
- Equivalent Combination of Education and Experience
About Exelixis
exelixis.comExelixis is an oncology-focused biotech company innovating cancer treatments for life. Find out how we're dedicated to giving more patients hope for the future.
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