Director or Senior Director of Regulatory Affairs

HIRING: (Senior) Director, Regulatory Affairs - Cell Therapy Biotech - Massachusetts
Hays Life Sciences is exclusively partnered with a growing biotechnology company to assist them in their search for a (Senior) Director, Regulatory Affairs to be based in Massachusetts. This is a Head of Regulatory Affairs position for the company. This is an innovative company looking to advance efforts in the immuno-oncology space. With several promising product candidates in the clinic, they are poised to be an important player for years to come. The (Senior) Director, Regulatory Affairs will be the first Regulatory Affairs employee within the organization and as such, this is a very important addition to the team.

In this capacity, you will develop regulatory strategies for the US and EU and lead the preparation of regulatory submissions such as INDs, CTAs, annual reports, NDAs, MAAs and briefing packages. You will represent Regulatory Affairs in meetings with regulatory authorities, provide regulatory guidance to project teams, and write regulatory documents to support regulatory submissions. In addition, you will coordinate activities with external publishing resources and manage submissions activities with contract research organizations (CRO).

At minimum, you must possess a Bachelor’s degree in a scientific discipline, 5+ years of Regulatory Affairs pharmaceutical industry experience, and experience writing regulatory submissions. Experience working in cell therapy or gene therapy is required. Cell therapy experience, specifically engineered adoptive cell therapies, is preferable. In addition, experience with an IND filing in cell therapy is required. Having Regulatory CMC experience in cell therapy is a bonus.

Apply now for consideration.


Job type:
Full Time
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

Telephone: 212 548 4525

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