Executive Director, Regulatory Affairs

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

• 20+ years
  of progressive Regulatory Affairs leadership within biotech/pharma.
• Track record of 9+ successful regulatory approvals
  (flexible based on complexity and stage of programs), with direct FDA engagement experience.
• Demonstrated regulatory expertise across
  small molecules, biologics, oncology, and advanced modalities
  —including
  cellular and gene therapies
  .
• Proven ability to partner effectively with C-suite, Board, and cross-functional leaders to drive strategic decision-making.
• Successful leadership within dynamic, fast-paced, and entrepreneurial biotech environments preferred.
• Exceptional communication, influence, and advisory skills, with the ability to simplify complexity and drive alignment.

What We Offer (Package & Benefits)

• Attractive executive-level consulting arrangement tailored to senior expertise.
• Fully
  remote
  work model with flexibility to attend key in-person leadership engagements as needed.
• Direct influence on high-impact programs with meaningful patient-centric outcomes.
• Opportunity to shape regulatory strategy and infrastructure at a pivotal stage of growth.

Why Join This Organisation?

• Opportunity to lead regulatory strategy for a
  cutting-edge, diversified pipeline
  with global impact potential.
• Join a science-driven, mission-led organization that values innovation, integrity, and collaboration.
• Engage directly with visionary leaders committed to advancing therapies that matter.
• High-impact role where your expertise will meaningfully shape company success and accelerate life-changing treatments to patients.