US Regulatory Strategy Lead

Responsibilities

• Develop and execute US regulatory strategies for assigned development and marketed products
• Serve as a core member of the Global Regulatory Team (GRT) to integrate US strategies into global plans
• Lead and facilitate major FDA meetings and manage the triage process for FDA Information Requests
• Evaluate and champion expedited regulatory pathways such as ODD, FTD, and Accelerated Approval
• Lead IND, NDA, and BLA submissions to the FDA in partnership with Regulatory Operations
• Act as the primary point of contact for the FDA and manage communications regarding product feedback
• Contribute to US product labeling in collaboration with Global Regulatory and Commercial teams
• Represent Regulatory on cross-functional project teams, including MDT and CAT

Requirements

• BS in a scientific discipline (Advanced degree such as PhD, PharmD, or MD preferred)
• 6+ years of regulatory affairs experience
• Proven experience leading FDA meetings and managing major applications (NDA/BLA or sNDA/sBLA)
• Strong leadership skills and high emotional intelligence
• Excellent verbal and written communication skills in English
• Ability to manage complex issues and coordinate multiple projects simultaneously

Preferred Qualifications

• Experience with immunology late-stage development or marketed products
• Deep understanding of GMP, GLP, and GCP regulations

Benefits

• Competitive compensation (Base salary range: $185,000 – $210,000 USD)
• Eligibility for short-term and long-term bonuses
• Generous time off policy
• Emphasis on work/life balance
• Opportunities to attend industry conferences

About the Company

Sobi is a specialized biopharmaceutical company dedicated to developing and delivering innovative therapies for people living with rare diseases. With over 1,900 employees in more than 30 countries, we are committed to making a positive impact on the lives of patients through science and strong partnerships.