Manager or Associate Director of Regulatory Operations

HIRING: Manager or Associate Director, Regulatory Operations - Growing Biotech - New Jersey

Hays Life Sciences is currently partnered with a rapidly growing biotechnology company to assist in their search for a Manager or Associate Director, Regulatory Operations to be based in New Jersey. This company is focused on advancing their cell therapy pipeline and 2019 is an important year for them as they further advance their developmental efforts. The Manager or Associate Director, Regulatory Operations will work in a highly visible position and as a result, this will be a very important addition to the company.

In this capacity, reporting to the Head of Regulatory Affairs, you will be responsible for managing the implementation of Veeva systems for regulatory submission and documentation management. You will serve as the Regulatory Operations Lead, supporting several IND submissions. You will publish all submission source documentation and submission dossier compilation. In addition, you will plan, prepare, track and archive regulatory submissions and documents.

At minimum, you must possess a Bachelor’s degree in a scientific discipline, 4+ years of eCTD publishing experience in the pharmaceutical industry, and experience with Veeva systems. Bilingual in Mandarin is a bonus as well as experience with CAR-T, cell, or gene therapy.

Apply now for consideration.


Job type:
Full Time
New Jersey
Life Sciences
Competitive / Based on Experience
Apply Now

Talk to a consultant

Talk to Phu Huynh, the specialist consultant managing this position, located in New York City

16th Floor, 200 West 41st St, New York, New York, NY 10036

Telephone: 212 548 4525

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