Global Regulatory Strategy Leader

Tarsus Pharmaceuticals

Irvine (CA)

Hybrid

USD 188,000 - 264,000

Full time

7 days ago

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Benefits offered by this job

Office in Irvine

Hybrid work environment

Stock equity

Job summary

Tarsus Pharmaceuticals in Irvine, CA, is seeking a Director of Regulatory Strategy to lead global regulatory activities with emphasis on US regulatory affairs pre- and post-approval. You will serve as regulatory lead for assigned projects and guide IND/CTA/NDA/MAA submissions, ensuring timing and quality.

The role requires 10+ years in regulatory affairs and an MS/PhD/PharmD, with strong communication, leadership, and project management skills.

Qualifications

Minimum 10 years of regulatory affairs experience with leadership roles.
Strong understanding of US FDA and international guidance and drug development.
Excellent written and verbal communication and negotiation skills.

Responsibilities

Provide regulatory leadership on project teams for development and clinical regulatory affairs.
Lead or oversee preparation of regulatory submissions (IND/CTA/NDA/MAA) and post-approval activities.
Interpret regulatory authority feedback and communicate requirements to teams.
Develop regulatory strategic plans and ensure timely, high-quality submissions.
Collaborate with cross-functional leads to plan, prioritize, and supervise activities.
Mentor junior regulatory strategists and support business development/regulatory due diligence.
Establish best practices and contribute to regulatory policy development.