Who can apply: Only open to applicants in: California.
Location as listed by the employer: “San Francisco, CA or Remote or Hybrid”
Apply on Braveheart Bio's site ↗
Opens the employer's official application page.
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About this role
Braveheart Bio is hiring for a Senior Manager, Regulatory Affairs role. See the official posting for full details.
Requirements
- Bachelor’s degree
- Minimum of 7 years of regulatory affairs experience in biotech or pharmaceutical drug development, with a strong focus on U.S., EU, and ex-U.S. clinical trial submissions
- Demonstrated hands-on experience with U.S. IND submissions, EU CTA submissions in CTIS, ex-U.S. CTA preparation and coordination, and health authority interactions and response management
- Strong knowledge of U.S. FDA regulations (including 21 CFR Parts 312 and 314), EU regulatory frameworks (including EU CTR 536/2014), EMA guidance and CTA requirements, and applicable ICH guidelines
- Experience managing IND and CTA lifecycle activities (amendments, updates, and maintenance)
- Strong project management and organizational skills, with the ability to work independently, manage multiple priorities, and meet deadlines in a lean, fast-paced environment
- Demonstrated ability to write clear, accurate regulatory documents
- Detail-oriented with a commitment to quality and compliance
Summarized from the employer's posting — check the full posting for every requirement.
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