Director, Global Regulatory Strategy - Biologics & mAb

Regulatory Jobs; Henderson (NV); Hybrid; USD 196,000 - 236,000; Full time

Benefits offered by this job

Medical plan

Dental plan

Vision plan

Life insurance

Disability insurance

HSA/FSA

Equity compensation

Bonus program

401(k) match

Paid time off

Parental leave

Job summary

Zura is seeking a Director of Global Regulatory Strategy to lead regulatory planning for monoclonal antibody programs and biologic-device combinations. You will craft global regulatory strategies, manage health authority interactions, and supervise regulatory submissions to support clinical development and global commercialization.

The role requires a minimum of 10 years in pharma/biotech, with substantial experience in regulatory affairs, and a track record of leading complex programs across

Qualifications

• 10+ years in pharmaceutical/biotech with 8+ years in regulatory affairs.
• Proven track record leading global regulatory strategy for complex programs.
• Experience with major health authority interactions (FDA EoP2).
• Understanding of biologics regulatory requirements and ICH/GCP.

Responsibilities

• Lead development and execution of regulatory strategies for assigned programs across global markets.
• Oversee health authority interactions (FDA EoP2, EMA) and primary contacts for programs.
• Plan, coordinate, and execute global regulatory submissions (INDs, CTAs, amendments) and regulatory notifications.
• Identify regulatory risks and propose mitigations to protect timelines and approvals.
• Mentor/regulate the regulatory sub-team and align with cross-functional teams.

Skills

Global regulatory strategy

Health authority interactions

Regulatory submissions

Leadership

Education

Bachelor’s degree in science

Advanced degree or certification

Job description

Zura is seeking a Director of Global Regulatory Strategy to lead regulatory planning for monoclonal antibody programs and biologic-device combinations. You will craft global regulatory strategies, manage health authority interactions, and supervise regulatory submissions to support clinical development and global commercialization.

The role requires a minimum of 10 years in pharma/biotech, with substantial experience in regulatory affairs, and a track record of leading complex programs across