Executive Director, Regulatory Affairs (Consultant)

Job Title : Executive Director, Regulatory Affairs (Consultant)

Location : Boston

Industry : Biotech / Pharmaceutical Innovation

Type : Remote

About the Opportunity

We are seeking a distinguished Executive Director–level Regulatory Affairs Consultant to partner with our leadership team and guide regulatory strategy across a diverse and innovative portfolio. This role is ideal for a seasoned regulatory professional with a proven track record of shepherding programs from early development through successful approvals, and who is energized by contributing at a strategic, high-impact level.

This is a high-profile consulting engagement supporting transformative advancements in small molecules, biologics, oncology, and cell & gene therapies —with the ability to influence portfolio decisions and shape the regulatory roadmap for assets with first-in-class potential.

Role Overview

As a senior regulatory advisor, you will serve as a key strategic thought partner to the Executive Team, owning global regulatory strategy and execution across multiple therapeutic programs. You will provide expert guidance on regulatory pathways, oversee major submissions, and represent the organization in interactions with regulatory agencies, ensuring alignment with evolving scientific and regulatory expectations.

Key Responsibilities

• Define, lead, and execute global regulatory strategy across early- and late-stage programs (pre-IND through approval and beyond).
• Drive preparation, authorship, and review of key submissions including INDs, NDAs, BLAs, and FDA meeting packages ; support ex-US filings as appropriate.
• Represent the organization in regulatory interactions, including FDA and other health authority meetings; prepare cross-functional teams for engagements.
• Advise on clinical development strategy, labeling, CMC considerations, and lifecycle management from a regulatory perspective.
• Anticipate regulatory risks and create proactive mitigation strategies to ensure program success.
• Mentor and influence internal teams, helping build scalable and compliant regulatory processes and infrastructure.
• Stay current with global regulatory landscape, scientific trends, and policy evolutions relevant to the therapeutic areas.

Qualifications & Experience

What We Offer (Package & Benefits)

Why Join This Organisation?