Sr Director, Regulatory Affairs Strategy
Tarsus Pharmaceuticals, Inc.
August 15, 2026
Remote friendly (California, United States)
United States
Corporate Functions
Role Summary
- Provide strategic and tactical regulatory leadership across product development, filing, and lifecycle management to ensure timely US and international approvals and compliant post-market performance.
Responsibilities
- Lead cross-functionally by collaborating across organizational levels and influencing cross-functional decision-making to drive regulatory success.
- Oversee development and execution of global regulatory strategies from early development through post-approval for complex assets/indications.
- Lead global regulatory strategy and manage major US/global regulatory submissions, rollout, and lifecycle management for marketed products including post-approval changes to maintain continuous compliance.
- Represent regulatory affairs in governance and interactions with global health authorities as applicable.
- Own US regulatory submissions and approvals for assigned projects.
- Identify and communicate regulatory hurdles, risks, opportunities, and innovative pathways to accelerate development and approval.
- Develop regulatory intelligence gathering and regulatory influence management at the portfolio level.
- Provide leadership and development to other regulatory strategists to ensure fit-for-phase strategies from FIH to approval.
- Lead regulatory strategy for business development and due diligence (assessment, risk identification/mitigation, precedent leverage, regulatory probability of success).
- Establish best practices across Regulatory Affairs and other R&D functions; lead development of regulatory policies/procedures; ensure regulatory record keeping.
- Participate in and lead professional associations/industry groups as appropriate for assigned projects.
Qualifications
- 15+ years of regulatory affairs experience (US and ex-US).
- MS, Ph.D., or PharmD in a scientific discipline.
Skills/Requirements
- Strong written and verbal communication.
- Critical thinking, leadership, assertiveness, negotiation, and project management skills.
- Deep understanding of US FDA and international pharmaceutical guidance/regulations and drug development.
- Ability to prioritize, coordinate, and thrive in a fast-paced environment.
- Strong decision-making, collaboration/team-building, outcome orientation, business acumen, and innovative mindset.
Travel
- Up to 20%.
Compensation/Benefits
- Expected base pay range: $226,500–$317,100 plus bonus, stock equity, and comprehensive benefits (health, dental, vision) and generous paid time off.
Work Location
- Irvine office (hybrid; remote work may be considered).
- Provide strategic and tactical regulatory leadership across product development, filing, and lifecycle management to ensure timely US and international approvals and compliant post-market performance.
Responsibilities
- Lead cross-functionally by collaborating across organizational levels and influencing cross-functional decision-making to drive regulatory success.
- Oversee development and execution of global regulatory strategies from early development through post-approval for complex assets/indications.
- Lead global regulatory strategy and manage major US/global regulatory submissions, rollout, and lifecycle management for marketed products including post-approval changes to maintain continuous compliance.
- Represent regulatory affairs in governance and interactions with global health authorities as applicable.
- Own US regulatory submissions and approvals for assigned projects.
- Identify and communicate regulatory hurdles, risks, opportunities, and innovative pathways to accelerate development and approval.
- Develop regulatory intelligence gathering and regulatory influence management at the portfolio level.
- Provide leadership and development to other regulatory strategists to ensure fit-for-phase strategies from FIH to approval.
- Lead regulatory strategy for business development and due diligence (assessment, risk identification/mitigation, precedent leverage, regulatory probability of success).
- Establish best practices across Regulatory Affairs and other R&D functions; lead development of regulatory policies/procedures; ensure regulatory record keeping.
- Participate in and lead professional associations/industry groups as appropriate for assigned projects.
Qualifications
- 15+ years of regulatory affairs experience (US and ex-US).
- MS, Ph.D., or PharmD in a scientific discipline.
Skills/Requirements
- Strong written and verbal communication.
- Critical thinking, leadership, assertiveness, negotiation, and project management skills.
- Deep understanding of US FDA and international pharmaceutical guidance/regulations and drug development.
- Ability to prioritize, coordinate, and thrive in a fast-paced environment.
- Strong decision-making, collaboration/team-building, outcome orientation, business acumen, and innovative mindset.
Travel
- Up to 20%.
Compensation/Benefits
- Expected base pay range: $226,500–$317,100 plus bonus, stock equity, and comprehensive benefits (health, dental, vision) and generous paid time off.
Work Location
- Irvine office (hybrid; remote work may be considered).