Associate Director/Director Regulatory Affairs - CMC Not right for you? We've got others

$120,000 - $180,000
Woodcliff Lake, NJ
January 11th 2021
Minimum Degree:
Bachelor of Science
Relocation Assistance:
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Our client is an advanced clinical-stage biopharmaceutical company developing novel therapeutics for orphan and common neurodegenerative diseases that currently lack curative and/or disease-modifying treatments.  Founded by renowned scientists, this company develops new therapeutics using proprietary technology and techniques.  


Position Summary: 

We are currently looking for an Associate Director/Director Regulatory Affairs to join the team.  This is a dynamic role for a growing company.  It reports to the Chief Regulatory Officer located in Europe and will lead the Regulatory Affairs function in the United States.

Primary Responsibilities 

  1. Acts as the Company’s point of contact for the FDA
  2. Strong background in chemistry/biologics and experience with Module 3 components of INDs/IMPDs and NDAs/MAAs
  3. Work with the Head of CMC to develop a regulatory strategy
  4. Participate in submissions to the FDA, including IND and NDA applications


Work Environment:

This is a fast-paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required. 

Ongoing search to fill this position is occurring during the COVID-19 New Jersey Statewide Stay at Home Order and as such, job functions may start out as a work from home position with the intent being that they will transition back to in-office along the same timeline as the rest of the in-office personnel.


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