Senior Director, Global Regulatory Strategy & Acceleration

Tarsus Pharmaceuticals, Inc.; Irvine (CA); Hybrid; USD 227,000 - 317,000; Full time

Benefits offered by this job

Bonus

Stock equity

Comprehensive benefits

Hybrid work environment

Job summary

Tarsus Pharmaceuticals, Inc. is seeking a Senior Director, Regulatory Affairs Strategy based in Irvine.

The role provides regulatory thought leadership across development, filing, and lifecycle management to assure timely US and international approvals and compliant post-market performance. The candidate must have at least 15 years in regulatory affairs with a MS/Ph.D./PharmD and strong leadership, negotiation, and cross-functional collaboration skills.

Qualifications

• Requires at least 15 years of regulatory affairs experience in US and international environments.
• Higher degree (MS, Ph.D. or PharmD) in a scientific discipline is required.
• Excellent written and verbal communication, leadership, and project-management skills.

Responsibilities

• Lead regulatory strategy across development, filing, and lifecycle management to ensure timely approvals.
• Oversee global regulatory submissions (US and international) and lifecycle management for complex assets.
• Engage with global health authorities and internal stakeholders to drive efficient development pathways.
• Identify regulatory hurdles, risks, and opportunities, and propose accelerated paths to approval.
• Develop regulatory intelligence and influence management at portfolio level.
• Provide leadership and mentorship to other regulatory strategists across programs.
• Represent Regulatory Affairs in governance and cross-functional teams.

Skills

Regulatory strategy

Regulatory leadership

US FDA guidance

Cross-functional collaboration

Regulatory risk management

Mentoring/regulatory team

Education

MS/PhD/PharmD in scientific discipline

Job description

Tarsus Pharmaceuticals, Inc. is seeking a Senior Director, Regulatory Affairs Strategy based in Irvine.

The role provides regulatory thought leadership across development, filing, and lifecycle management to assure timely US and international approvals and compliant post-market performance. The candidate must have at least 15 years in regulatory affairs with a MS/Ph.D./PharmD and strong leadership, negotiation, and cross-functional collaboration skills.