Senior Regulatory Affairs Leader — Strategy & Submissions

BeOne Medicines; California (MO); On-site; USD 150,000 - 230,000; Full time

Job summary

BeOne Medicines seeks an experienced regulatory leader to manage, evaluate, and complete regulatory projects aligned with company goals. The role develops, implements, and advises on regulatory strategies for development programs to secure market access and maintain lifecycle obligations.

The Associate Director will provide strategic regulatory guidance, interface with Health Authorities, and lead department processes to ensure timely, high-quality regulatory deliverables across all development

Qualifications

• Bachelor's degree with 8+ years' regulatory experience.
• Experience leading regulatory teams and FDA interactions.
• Strong ability to develop and implement regulatory strategies.
• Advanced degree preferred.

Responsibilities

• Accountable for regulatory deliverables and milestones including strategic plans.
• Provide leadership on regulatory strategy for development programs.
• Oversee submissions (IND/CTA, NDA/MAA) and health authority interactions.
• Liaise with regulatory authorities to expedite approvals and label changes.
• Mentor junior staff and lead regulatory team development.

Job description

BeOne Medicines seeks an experienced regulatory leader to manage, evaluate, and complete regulatory projects aligned with company goals. The role develops, implements, and advises on regulatory strategies for development programs to secure market access and maintain lifecycle obligations.

The Associate Director will provide strategic regulatory guidance, interface with Health Authorities, and lead department processes to ensure timely, high-quality regulatory deliverables across all development