Head of Regulatory Affairs

1 month ago


San Diego, United States Trebla Talent Full time

Role:

Vice President or Senior Vice President of Regulatory Affairs

San Diego - Hybrid


Company Description:

This is a pioneering cell therapy biotech focused on developing innovative immunotherapies for cancer treatment. They’ve had a fantastic 2024 following their IPO, and announcement of their autoimmune portfolio. Due to the promise of their technology, they’ve attracted some of the most talented scientists and now, clinical professionals to take their programs through development.


Culture Description:

They foster a vibrant and intellectually stimulating environment where collaboration thrives. A shared passion for innovation unites the team. They believe that great ideas flourish when diverse minds come together


Role Description:

As the Head of Regulatory Affairs, you will be a pivotal leader within the company, driving strategic regulatory decisions across the entire portfolio. You’ll lead a growing regulatory team, currently two members strong (Senior Director and Senior Manager levels), and play a key role on the leadership team, 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:

Bachelor’s Degree in a Life Sciences sector. Advanced degree preferred but not required.

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

Experience with Autoimmune required; cell therapy experience is a strong preference.

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

Previous experience in a small company setting.


If you are interested in this position, please apply here or send me an email at Natalia.pj@treblatalent.com



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