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Expertise · 04

Regulatory Affairs

Regulatory leaders turn science into an approvable story. We find strategists, writers and operators who have stood in front of FDA and global agencies, and who know when to push and when to listen.

Are you ready to file, and ready to be questioned? Expertise that brings clarity, rigor and judgment to the path ahead.

Roles we place

Leadership and specialist
talent across regulatory affairs.

Regulatory strategy, regulatory CMC, operations and publishing, labeling, advertising and promotion, and global regulatory leadership.

Leadership

  • Chief Regulatory Officer
  • VP Regulatory Affairs
  • Head of Regulatory Strategy
  • Head of Regulatory CMC
  • Head of Global Regulatory

Senior specialists

  • Global Regulatory Lead
  • Regulatory CMC Director
  • Labeling Strategy Lead
  • Advertising & Promotion Review Lead
  • Regulatory Intelligence Lead

Specialists

  • Regulatory Writer
  • Regulatory Operations & Publishing
  • Regulatory CMC Writer
  • Regulatory Project Manager
  • eCTD Specialist
Where we add value

What makes a regulatory affairs
search work.

01

Agency experience, verified

We reference the meetings, submissions and outcomes candidates describe. Pre-IND, EOP2, BLA and NDA experience are not interchangeable.

02

Strategy and execution

Some programs need a strategist, some a builder of submissions, most need both. We define which before we search.

03

Interim cover

Filing windows do not wait. Our contract bench supports submissions while the permanent search runs.

Two leaders in quiet conversation beside a tall window
Engagement

Matched to the hire,
not the other way around.

Executive Search for leadership appointments, Hybrid Search for critical director-level hires, Contract & Interim for filings, readouts and gaps, and Team Build when you are creating the function.

Role profiles

Roles we recruit.

Next practice

Quality Assurance

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The next conversation

Brief us on your
regulatory affairs search.

A senior partner will respond within one business day.