Description

You will provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs, anticipating regulatory needs and developing robust global regulatory strategies that align with corporate goals. You will establish highly collaborative relationships with cross-functional teams to ensure alignment and effectiveness.

Requirements

• Degree in life sciences, pharmacy, medicine, or related fields
• Minimum 12 years in pharmaceutical/biotech industry or relevant work experience
• Minimum 8 years in Regulatory Affairs including regulatory strategy and leadership roles
• Proven success in developing and delivering global regulatory strategies and submissions
• Previous experience with NDA and/or global marketing application filings

Responsibilities

• Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs
• Anticipate regulatory needs to deliver on program milestones
• Develop robust global regulatory strategies that reflect global marketing application filing strategies
• Establish highly collaborative and effective relationships with cross-functional teams