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Executive Director, Regulatory Affairs

2 months ago

waltham, United States Trebla Talent Full time

Role:

Executive Director or Vice President, Regulatory Affairs

Massachusetst - Hybrid


Company Description:

This pre-IPO, clinical-stage biotech, a spinoff from MIT and Harvard, is a key player in advancing cancer and autoimmune treatments through cutting-edge immunotherapies. Its technology is the first to develop novel immune cell engager therapies like theirs


Role Description:

As the Executive Director/Vice President, you will be a pivotal leader within the company, driving strategic regulatory decisions across the entire portfolio. You’ll lead a growing regulatory team, and will be reporting directly to the c-suite. In this hands-on role, you’ll bring both tactical execution and strategic insight, helping the company navigate global regulatory pathways. The ideal candidate thrives in a dynamic environment, is eager to roll up their sleeves, and is committed to fostering collaboration and innovation.


Qualifications:

10+ years of Regulatory Affairs experience within a pharmaceutical or biotech setting.

Experience with Oncology/ImmunoOncology required

Expertise in IND/CTA, and BLA/MAA submissions, with strong knowledge of FDA and global regulations.

Previous experience in a small company setting.