US Regulatory Strategy Lead

Job Summary

Leading the US Regulatory Strategy for assigned products, the full-time US Regulatory Strategy Lead will manage regulatory frameworks, collaborate with cross-functional teams, and ensure timely submissions to the FDA while working remotely.

Key Responsibilities:

• Collaborate with the Global Regulatory Team to integrate US strategies into global initiatives
• Prepare cross-functional teams for major FDA meetings and lead communications with the Agency
• Develop and implement US regulatory strategies, including risk assessments and expedited pathways for product access

Required Qualifications:

• BS in a scientific discipline; advanced degree (PhD, PharmD, MD) preferred
• 6+ years of regulatory affairs experience, including leading health authority meetings (FDA)
• Experience with late-stage development or marketed products in immunology is ideal
• Strong leadership skills and emotional intelligence
• Proven track record in risk assessment and regulatory compliance