Regulatory Submissions Lead, FDA; IND​/NDA​/BLA)

BeOne Medicines Ltd. is seeking a Senior Associate Regulatory Affairs to manage U.S. submissions (INDs, NDAs, BLAs) for investigational and commercial products. You will coordinate cross-functional teams, ensure FDA compliance, and drive submissions to on-time completion.

The ideal candidate has hands-on U.S. IND experience, proficiency with eCTD, and strong communication. BeOne offers a comprehensive benefits package and a path to equity, with a collaborative, fast-paced environment.

Our team is growing, and we are hiring a Regulatory Submissions Lead, FDA (IND/NDA/BLA) in United States.

The following position is for a Regulatory Submissions Lead, FDA (IND/NDA/BLA) with BeOne Medicines Ltd.

This Full Time position is for the Regulatory Submissions Lead, FDA (IND/NDA/BLA) role at BeOne Medicines Ltd.

We are seeking a motivated Regulatory Submissions Lead, FDA (IND/NDA/BLA) to join BeOne Medicines Ltd. in United States.