Senior Manager, Regulatory Affairs

🕒 October 6

🏄 California – Remote

🏄 California – Remote

💵 $170k - $195k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 15%

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Braveheart Bio

WebsiteLinkedInAll Job Openings

1 - 10 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Braveheart Bio is a clinical-stage biotechnology company focused on transforming the care of hypertrophic cardiomyopathy (HCM) and related conditions. The company is developing investigational therapies that selectively target overactive myosin — a key disease mechanism in HCM — and is advancing a program through global late-stage (Phase 3) clinical development to improve heart performance and patient quality of life.

📋 Description

• Manage preparation and coordination of U.S. IND submissions • Ensure IND submissions contain required documents and meet FDA requirements • Provide regulatory guidance on U.S. IND processes, FDA meeting requests, and briefing packages • Manage FDA information requests and sponsor responses • Support FDA regulatory interactions and IND maintenance activities, including protocol amendments, information amendments, CMC changes, safety reports, annual reports, and notifications • Support NDA submissions, including coordination of module content and pre-NDA meeting packages • Track U.S. submission status and maintain inspection-ready documentation and regulatory archives • Manage preparation, compilation, and submission of ex-U.S. CTAs, including EU CTIS and country-specific applications • Ensure CTA packages meet regional and country-specific requirements • Provide guidance on EU CTIS and country-specific CTA processes • Manage health authority questions and sponsor responses • Support CTA maintenance activities, including substantial modifications, IMPD updates, quality changes, annual updates, and notifications • Support preparation of MAAs and other ex-U.S. marketing applications • Track ex-U.S. submission status and maintain inspection-ready documentation and regulatory archives • Contribute to global regulatory strategy, health authority engagement plans, and submission timelines • Monitor evolving U.S., EU, and ex-U.S. regulatory requirements and assess their impact on development plans • Oversee regulatory vendors to ensure quality and on-time delivery • Serve as regulatory liaison across internal teams and external partners • Partner with Clinical Development and Clinical Operations on global study start-up timelines • Collaborate with CMC and Quality teams on IND, IMPD, and quality documentation • Report to the Vice President of Regulatory Affairs

🎯 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 • Strong knowledge of EU regulatory frameworks, including EU CTR 536/2014, EMA guidance and CTA requirements, and applicable ICH guidelines • Experience managing IND and CTA lifecycle activities, including amendments, updates, and maintenance • Strong project management and organizational skills • 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 • Strong written and verbal communication skills with a collaborative, team-oriented approach • Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity • Flexible, proactive, and hands-on mindset • Advanced degree (MS, PhD, PharmD) preferred • Preferred experience with regulatory submissions in the UK, Canada, Australia, South Korea, or LATAM • Preferred experience supporting NDAs and MAAs • Preferred experience in cardiovascular, rare disease, or small molecule drug development • Familiarity with ex-U.S. CMC regulatory requirements preferred • Experience with Veeva RIM or similar document management systems preferred • Employment authorization verified through the federal E-Verify program

🏖️ Benefits

• Competitive total rewards package • Annual bonus eligibility • Equity eligibility • Comprehensive benefits offering

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