Regulatory Affairs

Regulatory

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

As of 8/14/2019 the Regulatory Affairs team is actively partnering on the following searches:

Vice President of Regulatory Affairs, Gene Therapy Ophthalmology, New York City
Head of Regulatory Affairs, Neuroscience, San Francisco, CA
Senior Director/Head of Regulatory Affairs, NASH, San Francisco, CA
Senior Director/Director of Regulatory Affairs, Aesthetics, San Francisco, CA
Senior Director/Director of Regulatory Affairs, Gene Therapy Rare Diseases, Virtual
Senior Director/Director of Regulatory Affairs, Small Molecule Rare Disease, San Francisco, CA
Senior Director/Director of Regulatory Affairs, Gene Therapy Rare Diseases, Boston, MA
Senior Director/Director of Regulatory Affairs CMC, Small Molecules, San Francisco, CA
Senior Director/Director of Regulatory Affairs, Cell &Gene Therapy Rare Diseases, San Francisco, CA
Director/Senior Director of Regulatory Affairs CMC, Cell & Gene Therapy, Boston, MA
Regulatory Affairs Leader, Rare Diseases, Philadelphia, PA
Regulatory Affairs Leader, Neuroscience, Philadelphia, PA
Director of Regulatory Affairs CMC, Gene Therapy, San Francisco, CA
Director of Regulatory Affairs Labeling, San Francisco, CA

Sample of Recently Completed Searches

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