Regulatory Affairs Director

HIRING: Associate Director/Director, Regulatory Affairs - Growing Biotech - Maryland
Hays Life Sciences is currently partnered with a rapidly growing oncology biotechnology company to assist them in their search for a Regulatory Affairs Director to be based in Maryland. This company boasts an impressive portfolio of drug candidates targeted for various oncology indications. As they progress through clinical development, they are looking to fast-track their headcount growth. The Regulatory Affairs department is hiring multiple positions. The Regulatory Affairs Director will work in a highly visible capacity and as such, there is excellent career growth potential in this role.

In this capacity, you will be responsible for leading the preparation, compilation and review of multiple IND submissions. You will lead and execute regulatory strategies and manage regulatory interactions with health authorities at the FDA, EMA, among others. You will provide regulatory support to cross-functional teams, serve as the Regulatory contact on project teams, and explore regulatory pathways to product approval.

At minimum, you must possess a Bachelor’s degree in a scientific discipline, 5+ years of direct Regulatory Affairs project lead experience in the pharmaceutical or biotechnology industry, experience with direct FDA interaction and with IND filings, and regulatory strategy experience. Oncology experience is highly preferred as well as global Regulatory Affairs experience (US, EU, Canada, Japan, etc.).

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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