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  • Senior Director Regulatory Affairs, Oncology United States
  • Meet in United States, , United States
  • jobs
  • 6 days ago

jobs description

Meet is partnered with a clinical stage biotech focused within the Oncology space looking to hire a Senior/Executive Director Regulatory Affairs.

The ED/SD, Regulatory Affairs will help lead an upcoming BLA filing and serve as the liaison with the FDA and EMA for assigned programs...

Responsibilities:
• Co-lead BLA submission efforts across functions.
• Serve as a regulatory strategist and project lead for assigned programs.
• Establish, develop, and implement regulatory strategies in US and global markets.
• Monitor and interpret FDA and global Health Authority guidelines and policies; assessing potential impact on the business.
• Oversee document preparation and execution.
• Coach and mentor junior staff supporting the regulatory affairs team.

Qualifications:
• Recent hands-on experience with BLA submission.
• Experience functioning as the FDA point of contact, leading formal meetings and teleconferences.
• Demonstrated success developing and implementing regulatory strategies for US INDs, BLAs, and/or NDAs.
• Ability to lead a cross-functional team and manage project timelines.
• Familiarity with FDA content and technical requirements for BLA submissions.

Contact Information:

This position is being handled by Kasey Dillon at Meet, please contact on 646-517-0307 or [email protected] for additional information
United States

salary-criteria

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