Sr. Director, North America Regulatory Liaison

About the role

Inventiva is a clinical-stage biopharmaceutical company headquartered in France, focused on the development of lanifibranor in a Phase 3 trial, NATiV3, in MASH. To learn more, please visit: https://inventivapharma.com/

Key Responsibilities

• Contribute to and help shape regulatory submission strategies, identifying risks, mitigation plans, and opportunities.
• Provide strategic regulatory input into key development documents (e.g., clinical protocols, study reports, summaries).
• Apply knowledge of regional and global regulatory frameworks, trends, and requirements across all phases of development.
• Lead the planning, preparation, and delivery of regulatory submissions (simple to complex) across the product lifecycle.
• Develop and maintain submission delivery timelines, content plans, and execution strategies.
• Author and/or critically review submission components, ensuring quality and compliance.
• Manage regulatory applications and associated procedures through Health Authority approvals.
• Serve as primary point of contact with FDA.
• Lead or contribute to cross-functional submission teams to ensure timely and effective execution.
• Communicate clear, proactive status updates to stakeholders.
• Identify and drive process improvements, applying critical thinking and problem-solving skills.
• Demonstrate strategic thinking, including contingency planning aligned with business objectives.
• Influence decision-making across a matrixed organization.
• Represent the company externally with Health Authorities and industry partners, as appropriate.
• Build and leverage strategic relationships and networks.

Qualifications

• A minimum of a master’s degree in a scientific or technical discipline is required. Advanced degree (PharmD, Ph.D.) in a scientific or technical discipline preferred.
• Minimum of 10+ years of relevant regulatory experience.
• Experience in pharmaceutical, biotech industry is required.
• Experience in liver therapeutic area preferred.
• Strong knowledge of clinical drug development and regulatory pathways is required.
• Experience managing lifecycle submissions (e.g., IND, NDA, CTA, MAA) is required.
• Demonstrated experience preparing, reviewing, and delivering regulatory documentation is required.
• Proven track record interacting with FDA is required.
• Experience in people management/coaching/mentoring is preferred.

Why join us

Join Inventiva at a pivotal moment as we advance late-stage development and prepare for the next phase of growth. This is a unique opportunity to shape and lead North American regulatory strategy—guiding development pathways, driving high-quality Health Authority interactions, and influencing critical decisions that support successful product development and lifecycle management.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factor prohibited by law.