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 10/5/2017 the Regulatory Affairs team is actively partnering on the following searches:

Vice President of Regulatory Affairs CMC Biologics, San Francisco, CA
Vice President of Regulatory Affairs, Small Molecule, Pain, Philadelphia, PA
Head of Regulatory Affairs, Cell Therapy Oncology/Immuno-Oncology, Waltham, MA
Head of Regulatory Affairs, Gene Therapy, Houston, TX
Head of Regulatory Affairs, Generics, Philadelphia, PA
Head of Regulatory Affairs, Gene Therapy Ophthalmology/Rare Diseases, Lexington, MA
Head of Regulatory Affairs CMC Biologics/Gene Therapy, Boston, MA
Senior Director, Regulatory Affairs Oncology/Immunology, Respiratory, Mahwah, NJ
Senior Director, Regulatory Affairs CMC Biologics, New Jersey
Director, Regulatory Affairs Operations, San Diego, CA
Director, Regulatory Affairs CMC Biologics Pre-Approval, Philadelphia, PA
Director, Regulatory Affairs CMC Biologics Post-Approval, Philadelphia, PA
Director, Regulatory Affairs CMC Small Molecules Post-Approval, Philadelphia, PA
Director, Regulatory Affairs CMC Combination Products, Philadelphia, PA
Director, Regulatory Affairs CMC Vaccines, Philadelphia, PA

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)
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)
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)
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)
Director Ad Promo (Oncology) – (Chicago)
Global Regulatory Lead (Oncology) - (Boston)