Director of Regulatory Affairs - Trebla Talent : Job Details

Role:

Director 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 Director of Regulatory Affairs, you will be a pivotal leader within the company, driving strategic regulatory decisions across the entire portfolio. You'll co-lead a growing regulatory team, and play a key role within regulatory submission and strategy. This reports directly to the c-suite.

Qualifications:

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

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

Experience with Autoimmune is 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 [email protected]