Global Regulatory Lead (Director) - (US 100% Remote)

Comments:
This is for Regulatory Studio Suppliers Only.

This role is 100% remote, though EM is open to have the candidate work a hybrid schedule at the Cambridge Crossing site or any New Jersey Site if the candidate prefers.
Top Requirements:
Solid scientific background, Ph.D., M.D., PharmD, MS, or BS.
Minimum of 7 10 years of regulatory experience, with at least 3 years in U.S.
Experience preparing and filing INDs and managing early development programs required.
Pulmonology experience preferred but not required
Proven success leading Health Authority interactions, including FDA post-approval and pre-IND meetings required.

Job Description:
Job Title: Director, U.S. Regulatory Lead Post-Approval Immunology & Early Pulmonology Assets
Work Location: 100% remote
Department: Immunology & Cardiovascular / Global Regulatory Affairs

Position Summary
The Director, U.S. Regulatory Lead (USRL) will oversee regulatory strategy and execution for post-approval immunology assets, with a primary focus on management of Postmarketing Commitments (PMCs) and associated Health Authority (HA) interactions. The incumbent will also serve as Global Regulatory Lead (GRL)/USRL for an early pulmonology development asset, responsible for leading IND preparation and submission, and for developing the U.S. regulatory strategy across lifecycle phases.

Duties/Responsibilities
Lead U.S. regulatory strategy and execution for post-approval immunology assets, including lifecycle management and fulfillment of PMCs and PMRs, ensuring compliance with FDA commitments and timelines.
Manage and lead all HA interactions related to PMCs, including preparation of briefing packages, response documents, and post-approval correspondence with FDA.
Drive alignment of global and U.S. regulatory approaches for PMCs and post-approval deliverables, partnering with GRL and cross-functional teams.
Develop and maintain a U.S. post-approval regulatory strategy, including label maintenance, annual reports, and management of lifecycle submissions.
Serve as Global Regulatory Lead (GRL)/U.S. Regulatory Lead (USRL) for an early-stage pulmonology asset; lead preparation and filing of an Investigational New Drug (IND) application and development of regulatory component of integrated development plan for
Ensure documents and regulatory dossiers are compiled according to appropriate standards and guidelines.
Provide regulatory oversight of external vendors supporting PMC documentation, submission management, and lifecycle maintenance.
Proactively identify regulatory risks and propose mitigation strategies for all assigned programs.

Qualifications
Solid scientific background, Ph.D., M.D., PharmD, MS, or BS.
Minimum of 7 10 years of regulatory experience, with at least 3 years in U.S.
Experience preparing and filing INDs and managing early development programs required.
Pulmonology experience preferred but not required
Proven success leading Health Authority interactions, including FDA post-approval and pre-IND meetings required.
Deep understanding of U.S. regulatory frameworks for lifecycle management, post-marketing commitments, and development transitions.
Excellent in communicating regulatory strategy, issues, and risks in written and verbal format.
Experience leading cross-functional matrix teams.