Regulatory Affairs

The Regulatory Affairs practice at Klein Hersh is led by Colin Dittus, Jacob Kind, and Zachary Spitz. 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:

Colin Dittus                                           Zach Spitz
cdittus@kleinhersh.com                        zspitz@kleinhersh.com
215-830-9416                                       267-948-1429 

Jacob Kind Michael Perkel
jkind@kleinhersh.com                           mperkel@kleinhersh.com
215-830-8828                                       267-948-1446

Sample of Current Searches

**UPDATED 2/15/2017**
VP/SVP Regulatory Affairs-Microbiome
VP of Regulatory Affairs (Biologics)
Head of Regulatory Affairs-Gene Therapy/Gene Editing
Head of RA CMC, Small molecule drug development
Senior Director, Regulatory Affairs CMC
Senior Director, Head, Regulatory Affairs-NASH
Senior Director, Regulatory Affairs-Oncology
Director, Regulatory Affairs, Cell Therapy
Global Lead, Regulatory Affairs -Oncology
Global Regulatory Lead-IONC
Director- Global Regulatory Affairs-NDD/Immunology
Director, Regulatory Affairs CMC Small Molecule

Sample of Recently Completed Searches

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)