Senior Manager, Regulatory Affairs

The role

The Senior Manager, Regulatory Affairs will manage global regulatory submissions including U.S. IND and NDA activities and ex-U.S. CTA and MAA activities. This person will prepare submissions to global health authorities and help develop and execute regulatory strategy.

What you will do

• Manage the preparation and coordination of submissions to INDs
• Provide regulatory guidance on U.S. IND processes and requirements
• Manage FDA information requests and sponsor responses
• Support preparation for FDA regulatory interactions and IND maintenance activities
• Support preparation of NDA submissions
• Track U.S. submission status and maintain regulatory archives
• Manage the preparation, compilation, and submission of CTAs
• Provide regulatory guidance on EU CTIS and country-specific CTA processes
• Manage health authority questions and sponsor responses
• Support preparation of MAAs and other ex-U.S. marketing applications

Required qualifications

• Bachelor’s degree
• Minimum of 7 years of regulatory affairs experience in biotech or pharmaceutical drug development
• Strong focus on U.S., EU, and ex-U.S. clinical trial submissions
• Hands-on experience with U.S. IND submissions, EU CTA submissions in CTIS, and ex-U.S. CTA preparation and coordination
• Experience with health authority interactions and response management
• Strong knowledge of U.S. FDA regulations (21 CFR Parts 312 and 314)
• Strong knowledge of EU regulatory frameworks (EU CTR 536/2014), EMA guidance and CTA requirements, and applicable ICH guidelines
• Experience managing IND and CTA lifecycle activities
• Strong project management and organizational skills
• Ability to write clear, accurate regulatory documents
• Strong written and verbal communication skills

Nice to have

• Advanced degree (MS, PhD, PharmD)
• Experience with regulatory submissions in ex-U.S. regions such as the UK (MHRA), Canada (Health Canada), Australia (TGA), South Korea (MFDS), or LATAM
• Experience supporting the preparation of marketing applications (e.g., NDAs and MAAs)
• Experience in cardiovascular, rare disease, or small molecule drug development
• Familiarity with CMC regulatory requirements in ex-U.S. regions
• Experience with Veeva RIM or similar document management systems

Benefits

• Annual bonus
• Equity
• Comprehensive benefits offering

Before you apply

• Braveheart participates in the federal E-Verify program to confirm employment authorization for all new hires

About the company

Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases.