Global Regulatory Strategy Director (Remote/Hybrid)

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

Benefits offered by this job

Hybrid work environment

Onsite gym and facilities

Job summary

Tarsus Pharmaceuticals, based in Irvine, CA, seeks a Senior Director of Regulatory Affairs Strategy to guide development and lifecycle management with FDA expertise. The role requires leadership across US and international submissions, risk mitigation, and strategic regulatory planning in a fast-paced, entrepreneurial environment.

The candidate must have 15+ years in regulatory affairs and an advanced scientific degree (MD/PhD/PharmD).

Qualifications

• 15+ years of regulatory affairs experience in US and ex-US environments.
• Strong written and verbal communication skills.
• Ability to lead cross-functional teams and influence decisions.

Responsibilities

• Lead regulatory strategy from development through lifecycle management for complex assets.
• Oversee global regulatory submissions and lifecycle activities (US and international).
• Represent regulatory affairs in governance and interactions with health authorities.
• Identify regulatory hurdles, risks and opportunities to accelerate development and approval.
• Provide mentorship to other regulatory strategists and establish best practices.

Skills

Regulatory strategy

Leadership

Regulatory affairs

Drug development

Stakeholder management

Global regulatory

Education

MD/PhD/PharmD

Job description

Tarsus Pharmaceuticals, based in Irvine, CA, seeks a Senior Director of Regulatory Affairs Strategy to guide development and lifecycle management with FDA expertise. The role requires leadership across US and international submissions, risk mitigation, and strategic regulatory planning in a fast-paced, entrepreneurial environment.

The candidate must have 15+ years in regulatory affairs and an advanced scientific degree (MD/PhD/PharmD).