Senior Manager, Regulatory Affairs

Braveheart Bio

(Senior) Manager, Regulatory Affairs at Braveheart Bio focused on EU and ex-U.S. Clinical Trial Applications.

Posted 6/18/2026full-timeSan Francisco • California • 🇺🇸 United StatesSenior💰 $119,000 - $190,000 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

regulatory affairsEU CTA submissionsCTISCTA preparationhealth authority interactionsregulatory document writingCTA lifecycle managementquality documentationproject managementcompliance

Soft Skills

organizational skillsindependencemulti-priority managementdeadline managementdetail-orientedcommitment to qualitywritten communicationverbal communicationcollaborative approachadaptability

Certifications & Qualifications

Bachelor's degree

Industry Keywords

biotechpharmaceutical drug developmentEU regulatory frameworksEU CTR 536/2014EMA guidanceICH guidelinesclinical trial submissionsregulatory liaisonglobal study start-upinspection-ready documentation

About the role

Key responsibilities & impact

Manage the preparation, compilation, and submission of CTAs, including CTIS submissions and country-specific applications
Ensure CTA packages include all required documents (e.g., protocol, IB, IMPD, ICFs) and meet regional and country-specific requirements
Provide regulatory guidance on EU CTR, CTIS processes, and country-specific CTA requirements
Manage health authority questions and sponsor responses to support timely approvals
Support CTA maintenance activities, including substantial modifications, protocol amendments, IMPD updates, quality changes, annual updates, and notifications
Track submission status and maintain inspection-ready documentation and regulatory archives
Partner closely with Clinical Development and Clinical Operations to support global study start-up timelines
Collaborate with CMC and Quality teams to ensure accurate and compliant IMPD and quality documentation
Serve as a regulatory liaison across internal teams and external partners to ensure timely and compliant submissions across ex-U.S. markets

Requirements

What you’ll need

Bachelor’s degree
Minimum of 5 years of regulatory affairs experience in biotech or pharmaceutical drug development, with a strong focus on EU and ex‑U.S. clinical trial submissions
Demonstrated hands-on experience with EU CTA submissions in CTIS, CTA preparation and coordination, health authority interactions and response management
Strong knowledge of EU regulatory frameworks including EU CTR 536/2014, EMA guidance and CTA requirements, and applicable ICH guidelines
Experience managing CTA lifecycle activities (amendments, updates, and maintenance)
Strong project management and organizational skills, with 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 with a roll-up-your-sleeves, can-do attitude.

Benefits

Comp & perks

This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.