Regulatory Affairs Strategy Manager (Oncology)
Exelixis
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.
Skills
Qualifications
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.
Recent company news
BitgetExelixis (EXEL) Has Fallen 2.8% Since Its Previous Earnings Report: Is a Recovery Possible?
4 hours ago
Fierce PharmaExelixis aims to be a top-5 solid tumor drugmaker in the US: CEO
1 month ago
MarketBeatWhat is Zacks Research's Estimate for Exelixis Q3 Earnings?
3 days ago
Investing.com NigeriaExelixis Q4 2025 slides: Strong earnings growth amid oncology franchise expansion
2 days ago
Business WireExelixis to Webcast Fireside Chats as Part of Upcoming Investor Conferences in March
2 weeks ago
About Exelixis
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
Unlock Company Insights
View leadership team, funding history,
and employee contacts for Exelixis.
Salary
$125k – $177k
per year
More jobs at Exelixis
Similar Jobs
Regulatory Specialist-II -CTA/IND Development delivery
GSK plc
Director, Regulatory Affairs Strategy - Cardiovascular/Metabolic
Regeneron Pharmaceuticals
Director, Global Regulatory Project Management
BeOne Medicines
Director, Regulatory CMC
Neurocrine Biosciences
Regulatory affairs Manager
Integrated Resources INC
Regulatory affairs Manager
Integrated Resources INC