Regulatory Affairs

The Regulatory Affairs practice at Klein Hersh is led by Jacob Kind, Zachary Spitz, and Michael Perkel. In the past decade, we have played an instrumental role in supporting numerous Pharmaceutical & Biotechnology partners with key hires who drive product approvals and help to navigate the ever-changing Global Regulatory landscape.

Whether your need is for a key full-time addition to your Regulatory staff, or you need to engage a highly specialized consultant or contractor, Klein Hersh Delivers Regulatory experts spanning the full product lifecycle:

► Clinical Regulatory & Strategy                       ► Submissions and Regulatory Operations
► Regulatory CMC                                             ► Advertising & Promotional Review
► Global / International Regulatory Affairs        ► Labeling

For more information or to learn about other areas we can add value, please call or email:

Jacob Kind
jkind@kleinhersh.com            
215-830-8828  

Zach Spitz
zspitz@kleinhersh.com
267-948-1429

Michael Perkel
mperkel@kleinhersh.com
267-948-1446


Sample of Current Searches

**UPDATED 7/5/2017**
SVP of Regulatory Affairs, Oncology
Vice President of Regulatory Affairs, Gene Therapy
Head of Regulatory Affairs, Cell Therapy
Head of Regulatory Affairs-Microbiome
Senior Director of Regulatory, NASH
Senior Director of Regulatory Affairs, Oncology
Global Regulatory Lead, Oncology
Director of Regulatory Affairs-Anti-Infectives
Director of Regulatory Affairs-Stem Cell Therapy
Director of Regulatory Affairs CMC-Post Approval
Director of Regulatory Affairs CMC-Consumer Products
Director of Regulatory Affairs CMC, Small Molecule

Sample of Recently Completed Searches

Head of Regulatory Affairs, Gene Therapy/Gene Editing (Boston)
Senior Director of Regulatory Affairs, Microbiome (San Francisco)
Global Regulatory Affairs Lead, Oncology (Philadelphia)
Director of Regulatory Affairs, Immuno-Oncology (Boston)
VP RA (Pain) - (San Francisco)
VP Regulatory Affairs (Dermatology) - (Connecticut)
VP Oncology & Biosimilar Regulatory Affairs – (Boston)
VP RA and QA (Anti-Infective) – (Boston)
VP RA & QA (CNS)-(Southern California)
VP RA & QA (Hepatic/Live Disease) - (Chicago)
VP RA & QA (Sickle Cell) - (San Francisco)
Head of Regulatory Affairs (Pain) – (CT/NY)
Head of Regulatory Affairs & QA (Oncology, CNS, Rare/Orphan) -  (San Francisco)
Head of Regulatory Affairs (Immuno-Oncology)-(Philadelphia)
Executive Director Regulatory Affairs (Inflammation) - (San Diego)
Executive Director Regulatory Affairs (Oncology) – (New York/New Jersey)
Executive Director Global Regulatory Affairs (Rare/Orphan) - (New Jersey)
Head of Regulatory CMC Biologics (Immuno-Oncology Anti-PD1 Lead) – (Philadelphia)
Sr Director Ad Promo (Rare Disease) - (CT/NY)
Sr Director of Regulatory Affairs (Rare/Orphan) – (Boston)
Sr Director Regulatory Affairs (Rare/Orphan) – (San Diego)
Sr Director Regulatory Affairs (Biosimilar) – (San Diego)
Sr Director Regulatory Affairs (Immunology) – (Boston)
Sr Director Regulatory Affairs (Hematology) – (New Jersey)
Sr Director Regulatory Affairs (Orphan/Rare) - (San Francisco)
Director Ad Promo (Oncology) – (Chicago)
Global Regulatory Lead (Oncology) - (Boston)