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Braveheart Bio

Senior Manager, Regulatory Affairs

Braveheart Bio

. Manage preparation and coordination of U.S.

Posted 10/6/2026full-timeRemote • California • United StatesSenior💰 $170,000 - $195,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in managing U.S. IND and ex-U.S. CTA submissions, ensuring compliance with FDA and EU regulatory requirements. Possesses strong project management skills and the ability to collaborate effectively across teams while maintaining high-quality standards in regulatory documentation.

Highest-signal resume keywords
U.S. IND Submission ManagementEU CTA Submission CoordinationRegulatory Affairs ExperienceProject Management SkillsKnowledge of FDA Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory Submission PreparationIND Lifecycle ManagementCTA Maintenance ActivitiesRegulatory Document WritingKnowledge of 21 CFR Parts 312 and 314Knowledge of EU CTR 536/2014Health Authority Interaction ManagementRegulatory Strategy DevelopmentSubmission Status TrackingQuality Compliance
Soft Skills
Strong Communication SkillsDetail-OrientedAbility to Work IndependentlyCollaborative Team ApproachProactive Mindset
Tools & Technologies
Veeva RIMDocument Management Systems
Industry Keywords
BiotechPharmaceutical Drug DevelopmentClinical Trial SubmissionsNDA SubmissionsMAA PreparationRegulatory FrameworksICH GuidelinesGlobal Regulatory StrategyInspection-Ready DocumentationHealth Authority Engagement

About the role

Key responsibilities & impact
  • 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

What you’ll need
  • 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

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