Senior Director Regulatory Affairs

ERAPS - Executive Regulatory Affairs Professional Search; New York (NY); Remote; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

ERAPS - Executive Regulatory Affairs Professional Search seeks a Senior Director, Regulatory Affairs to lead US regulatory strategy and execution for late-stage programs. This pivotal role partners with global leaders to shape development pathways and manage high-quality Health Authority interactions throughout lifecycle.

You will drive end-to-end submissions, balance risk with opportunity, and influence decisions in a matrixed organization while guiding a team of regulatory professionals.

Qualifikationen

• Master's degree in a scientific or technical field required; advanced degrees preferred.
• Minimum of 9 years of regulatory experience in pharma/biotech.
• Experience with lifecycle submissions (IND, NDA, CTA, MAA) and FDA interactions.
• Liver therapeutic area experience is preferred and highly desirable.
• Strong knowledge of clinical drug development and regulatory pathways.

Aufgaben

• Lead US regulatory strategy and execution for assigned projects.
• Shape development pathways and ensure high-quality Health Authority interactions.
• Oversee end-to-end regulatory submissions across product lifecycle.
• Coordinate with global and cross-functional teams to align submission plans.
• Represent the company with Health Authorities and industry partners.

Kenntnisse

Regulatory leadership

FDA interactions

Regulatory strategy

Cross-functional collaboration

Project management

Communication

Stakeholder management

Leadership

Strategic thinking

Ausbildung

Master's degree in science/technical discipline

PharmD/PhD preferred

Jobbeschreibung

• Location: US (Remote/Field)


• Full Time


• Reports to: Chief Regulatory Officer

My client is a clinical-stage biopharmaceutical company focused on the development of novel treatment for patients who suffer from liver disease.

WHY JOIN?

This is a pivotal moment for my client that is in late-stage development, preparing for the next phase of growth. In this newly created position, you will be a global regulatory leader for US 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 be considered 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.

The Opportunity

The Sr. Director of Regulatory Affairs will serve as a strategic regulatory leader, US 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. You will be required to possess a strategic mindset, balancing risk mitigation with opportunity maximization to enable successful pipeline product development and lifecycle management.

The Sr. Director of Regulatory Affairs will be responsible for leading end-to-end exection and planning of assigned deliverables.

Key Responsibilities

Regulatory Strategy & Leadership:

• As the number 2 regulatory leader, you will 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 9 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.