Director, Regulatory Strategy – US FDA Leader

Tarsus Pharmaceuticals, Inc.; California (MO); Hybrid; USD 188,000 - 264,000; Full time

Benefits offered by this job

Onsite gym

Pool

Snacks and drinks

Occasional catered meals

Health insurance

Dental and vision insurance

Generous paid time off

Hybrid work environment

Job summary

Tarsus Pharmaceuticals, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory activities with a US focus, guiding pre- and post-approval submissions and project teams from FIH to approval. The role requires a minimum of 10 years in regulatory affairs and an advanced degree.

The position is based in Irvine with a hybrid work environment, some travel, and direct reporting to the VP, Regulatory Affairs. Competitive compensation and comprehensive benefits are provided.

Qualifications

• Minimum 10 years of regulatory affairs experience.
• Advanced degree (MS, PhD or PharmD).
• Experience leading regulatory submissions for IND/CTA/NDA/MAA.

Responsibilities

• Provide regulatory leadership on global projects with focus on US regulatory affairs.
• Lead or oversee pre- and post-approval submissions activities.
• Interpret regulatory guidance and communicate requirements to teams.
• Develop strategic regulatory plans and ensure timely submissions.
• Collaborate with cross-functional partners to prepare regulatory documents.
• Mentor and develop other regulatory strategists.
• Support BD and due diligence with regulatory assessments.
• Maintain and advance regulatory policies and procedures.

Skills

Regulatory leadership

Regulatory strategy

Project management

Communication skills

Team collaboration

Education

MS/PhD/PharmD

Tools

IND/CTA submissions

Job description

Tarsus Pharmaceuticals, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory activities with a US focus, guiding pre- and post-approval submissions and project teams from FIH to approval. The role requires a minimum of 10 years in regulatory affairs and an advanced degree.

The position is based in Irvine with a hybrid work environment, some travel, and direct reporting to the VP, Regulatory Affairs. Competitive compensation and comprehensive benefits are provided.