Global Regulatory Strategy Director

Welcome to the Tarsanet Internal Career Center!; Irvine (CA); Hybrid; USD 188,000 - 264,000; Full time

Benefits offered by this job

Onsite gym

Pool

Snacks & drinks

Catered meals

Hybrid work

Job summary

Tarsus Pharmaceuticals in Irvine, CA, seeks a Director of Regulatory Strategy to lead global regulatory activities for assigned products, with emphasis on US FDA programs, pre- and post-approval. You will act as regulatory lead on project teams, requiring 10+ years of regulatory affairs experience and an MS/PhD/PharmD.

Hybrid work and travel up to 10% are expected. The role reports to the VP, Regulatory Affairs and offers bonus, stock options, and comprehensive benefits.

Qualifications

• Requires at least 10 years of regulatory affairs experience with advanced degree.
• Strong written and verbal communication, leadership, and project management skills.
• Deep understanding of US FDA and international regulatory guidance and drug development.

Responsibilities

• Provide regulatory leadership on project teams with focus on development and clinical regulatory affairs.
• Oversee/prep regulatory submissions (IND/CTA/NDA/MAA) and ensure quality/timeliness.
• Collaborate with cross-functional teams to plan, prioritize, and execute submissions.
• Develop strategic regulatory plans and interpret regulatory feedback and guidelines.

Skills

Regulatory leadership

Regulatory affairs

Project leadership

US FDA knowledge

Education

MS/PhD/PharmD

Job description

Tarsus Pharmaceuticals in Irvine, CA, seeks a Director of Regulatory Strategy to lead global regulatory activities for assigned products, with emphasis on US FDA programs, pre- and post-approval. You will act as regulatory lead on project teams, requiring 10+ years of regulatory affairs experience and an MS/PhD/PharmD.

Hybrid work and travel up to 10% are expected. The role reports to the VP, Regulatory Affairs and offers bonus, stock options, and comprehensive benefits.