North America Regulatory Strategy Director

Inventiva; Minneapolis (MN); On-site; USD 180,000 - 240,000; Full time

Job summary

Inventiva is seeking a Sr. Director, North America Regulatory Liaison to lead regulatory strategy and execution for NA programs. You will drive interactions with FDA and other Health Authorities, shape development pathways, and coordinate end‑to‑end regulatory submissions across the lifecycle.

The role requires a strong strategic mindset, extensive regulatory experience in biotech/pharma, and proven leadership in a matrixed environment to enable successful pipeline progression.

Qualifications

• Master’s degree in a scientific or technical discipline required.
• Advanced degree (PharmD, Ph.D.) preferred.

Responsibilities

• Lead end‑to‑end NA regulatory strategy and execution for assigned projects.
• Partner with global and cross‑functional teams to shape development pathways and interactions with Health Authorities.
• Represent the company in FDA engagements and coordinate regulatory submissions across the product lifecycle.

Skills

Regulatory Strategy

FDA & Health Authority Engagement

Lifecycle Submissions

Cross-functional Leadership

Strategic Thinking

Communication Skills

Education

Master’s degree in a scientific or technical discipline

PharmD/Ph.D. preferred

Job description

Inventiva is seeking a Sr. Director, North America Regulatory Liaison to lead regulatory strategy and execution for NA programs. You will drive interactions with FDA and other Health Authorities, shape development pathways, and coordinate end‑to‑end regulatory submissions across the lifecycle.

The role requires a strong strategic mindset, extensive regulatory experience in biotech/pharma, and proven leadership in a matrixed environment to enable successful pipeline progression.