Senior Manager, Regulatory Affairs

The Senior Manager, Regulatory Affairs will play a key role in Braveheart Bio’s global regulatory submissions, spanning U.S. IND and NDA activities and ex-U.S. CTA and MAA activities. Reporting to the Vice President of Regulatory Affairs, this individual will prepare and manage submissions to global health authorities and help develop and execute regulatory strategy. The role requires strong knowledge of U.S. FDA regulations, the EU Clinical Trials Regulation, and hands-on experience navigating country-specific requirements in regions outside the U.S.