Sr. Director, North America Regulatory Liaison

Inventiva Pharma; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Inventiva is a clinical-stage biopharmaceutical company headquartered in France, focused on lanifibranor in a Phase 3 trial, NATiV3, in MASH. This leadership role shapes North America regulatory strategy to enable pipeline development and lifecycle management.

The Sr. Director North America Regulatory Liaison will drive end-to-end planning, coordinate with FDA and global teams, and lead submissions and health authority engagements to ensure timely, high-quality decisions.

Qualifications

• Master’s degree in a scientific or technical discipline required; PhD/ PharmD preferred.
• 10+ years of regulatory experience in pharma/biotech.
• Experience with IND, NDA, CTA, MAA submissions and FDA interactions.
• Strong leadership, stakeholder management, and matrixed environment capabilities.
• Experience in liver therapeutic area preferred.

Responsibilities

• Shape regulatory submission strategies and timelines.
• Lead planning and execution of regulatory submissions across product lifecycle.
• Coordinate Health Authority engagements, including FDA interactions.
• Collaborate with global/regional teams to align submission plans.
• Drive process improvements and strategic decision-making.
• Represent the company in interactions with Health Authorities and industry partners.

Skills

Regulatory leadership

FDA interactions

Cross-functional collaboration

Strategic thinking

Education

Master’s degree in science/engineering

Advanced degree (PhD/PharmD) preferred

Job description

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/

The Opportunity

The Sr. Director, North America Regulatory Liaison will serve as a strategic regulatory leader, driving North America regulatory strategy and execution for assigned projects. This role will partner closely with global and cross-functional leaders to shape development pathways, influence key decisions, and ensure high-quality, timely interactions with Health Authorities. The position will require a strategic mindset, balancing risk mitigation with opportunity maximization to enable successful pipeline product development and lifecycle management.

The Sr. Director North America Regulatory Liaison, will be responsible for leading the end-to-end planning, coordination and execution of assigned deliverables.

Key Responsibilities

Regulatory Strategy & Leadership:

• 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.

Submission Planning & Execution:

• 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.

Health Authority Engagement:

• Serve as primary point of contact with FDA
• Lead and coordinate Health Authority interactions, including preparation of briefing materials and responses.
• Manage responses to regulatory queries and requests.

Cross-functional Collaboration:

• Partner with global regulatory and cross-functional teams to align on submission and interaction plans.
• Lead or contribute to cross-functional submission teams to ensure timely and effective execution.
• Communicate clear, proactive status updates to stakeholders.

Operational Excellence & Influence:

• 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.

Representation & Networking:

• 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.
• A 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 .and other global Health Authorities is a plus
• Experience in people management/coaching/mentoring is preferred.
• Must have excellent communication and interpersonal skills.
• Must have strong stakeholder management skills.
• Must have the ability to exercise independent judgment in resolving complex regulatory and organizational challenges.
• Must have strong leadership capabilities with the ability to work successfully in a matrixed environment.
• The ability to effectively prioritize assignments for multiple products and projects simultaneously is required.
• The ability to collaborate with all levels and influence decision-making within a cross-functional organization is required.

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.