Remote - Director, Regulatory Affairs - Oncology

Company: CyberCoders
Location: Miami
Posted on: January 16, 2022

Job Description:

If you are a Director, Regulatory Affairs with experience, please read on!

We are a clinical-stage immune-oncology company developing first-in-class drugs to help people with cancer. Our lead candidates are at different stages in clinical trials.

Job Title: Director or Sr. Director, Regulatory Affairs

Job Location: Remote

Requirements: Previous submission experience; 10 years + prior experience in a biotech company; oncology experience

Top Reasons to Work with Us

• Be part of a fast growing company
• Join a pre-IPO biotech firm
• Great hiring manager
• Awesome location
  What You Will Be Doing
  
  As The Director Of Regulatory Affairs, You Will
  
  • Lead the preparation of submissions, including INDs, Briefing Documents, Marketing Applications
  • Develop, lead and implement global regulatory strategy
  • Develop strategies for submission to FDA and other global health authorities.
  • Partner with CROs
  • Support preparation of Orphan Drug designation request submissions to FDA and EMA
  • Support preparation of Pediatric Study Plans and other pediatric applications
    Benefits
    
    • Vacation/PTO
    • Medical
      So, if you are a Director, Regulatory Affairs with experience, please apply today!
      
      Colorado employees will receive paid sick leave. For additional information about available benefits, please contact Alexander Charles
      
      Email Your Resume In Word To
      
      Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also:
      
      Alexander.Charles@CyberCoders.com
      
      • Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : AC11-1668655L053 -- in the email subject line for your application to be considered.***
        Alexander Charles - Executive Recruiter - CyberCoders
        
        Applicants must be authorized to work in the U.S.
        
        CyberCoders, Inc is proud to be an Equal Opportunity Employer
        
        All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
        
        Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

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