Senior Director of Regulatory Affairs, CMC - Remote

Overview

BeOne is seeking an accomplished regulatory leader to head the U.S. Biologics Regulatory CMC organization, providing strategic and operational leadership for CMC activities and ensuring compliance with global regulatory expectations.

In Short

• Lead and develop the U.S. Biologics Regulatory CMC team.
• Provide strategic leadership for global biologics Regulatory CMC strategies.
• Oversee regulatory CMC interactions with Health Authorities.
• Manage CMC-related regulatory submissions and lifecycle management.
• Ensure compliance with evolving global regulatory expectations.
• Establish and improve Regulatory CMC standard operating procedures.
• Conduct regulatory risk management across the biologics portfolio.
• Represent the company in external forums and industry groups.
• Collaborate with cross-functional stakeholders for alignment.
• Review and approve Regulatory CMC documentation.

Requirements

• BA/BS in scientific disciplines, MS/PhD preferred.
• 12+ years of relevant pharmaceutical or biopharmaceutical experience.
• 10+ years of direct Regulatory CMC experience.
• Proven experience leading Health Authority interactions.
• Advanced scientific training in pharmaceutical or biologics disciplines.
• In-depth knowledge of ICH guidelines and global Regulatory CMC requirements.
• Excellent written and verbal communication skills.
• Strong interpersonal and problem-solving skills.
• Experience with Regulatory Information Management systems is a plus.
• Experience with gene therapy and medical device-combination products is desirable.

Benefits

• Competitive salary and equity options.
• Comprehensive benefits package including Medical, Dental, Vision.
• 401(k) with company match.
• Paid Time Off and Wellness programs.
• Equal opportunity employer with a commitment to diversity.