Principal Regulatory Affairs Consultant

Responsibilities

• Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents
• Handle FDA Type A, Type B, and Type C meetings
• Author NDA and BLA submissions and coordinate with Non-Clinical/Clinical teams
• Manage and submit forms and documents globally to ensure international compliance
• Lead meetings with FDA representatives and prepare briefing documents
• Serve as the main point of contact for clients regarding regulatory support
• Mentor and train new employees in regulatory affairs and FDA processes
• Evaluate proposed manufacturing and quality changes for impact on existing registrations

Requirements

• Bachelor’s degree in chemistry, pharmaceutics, biology, or a related scientific discipline
• Proven experience handling INDs, NDAs, BLAs, and global submissions
• Strong background in drug development, biologics, and clinical trials