North America Regulatory Strategy Director

Inventiva; United States; 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 projects. You will partner with global leaders to shape development pathways, influence key decisions, and ensure timely Health Authority engagements.

This role requires strategic thinking and strong leadership in a matrixed environment. You will oversee end-to-end planning and execution of regulatory deliverables, manage submissions, and serve as the primary FDA contact,

Qualifications

• Master's degree in a scientific or technical field required.
• 10+ years regulatory experience.
• Experience in pharmaceutical/biotech industry required.
• Experience with IND, NDA, CTA, MAA submissions.
• Strong FDA interactions and global Health Authority exposure.
• Leadership in matrixed environments.
• Excellent communication and stakeholder management.
• Ability to prioritize across multiple products.
• Liver therapeutic area experience preferred.

Responsibilities

• Contribute to and shape regulatory submission strategies, identifying risks and opportunities.
• Lead planning, preparation, and delivery of regulatory submissions across the product lifecycle.
• Serve as primary contact with Health Authorities and coordinate interactions.
• Collaborate with global/regional teams to align on submission plans and timelines.
• Drive process improvements and strategic thinking in regulatory operations.
• Represent the company externally with Health Authorities and industry partners.

Skills

Regulatory strategy

Regulatory leadership

Submission planning

Health Authority engagement

Cross-functional collaboration

Stakeholder management

Regulatory writing/review

Project management

Decision making

Influence & negotiation

Education

Master's degree in science/tech

PhD or PharmD preferred

Job description

Inventiva is seeking a Sr. Director, North America Regulatory Liaison to lead regulatory strategy and execution for NA projects. You will partner with global leaders to shape development pathways, influence key decisions, and ensure timely Health Authority engagements.

This role requires strategic thinking and strong leadership in a matrixed environment. You will oversee end-to-end planning and execution of regulatory deliverables, manage submissions, and serve as the primary FDA contact,