Compliance Manager overseeing United Rotorcraft’s compliance initiatives with federal standards. Ensuring audit readiness and managing supplier compliance and training programs.
About the role
- Director of Regulatory Affairs leading global regulatory strategy for Braveheart Bio’s Phase 3 HCM program. Collaborating with cross-functional teams and ensuring successful regulatory submissions.
Responsibilities
- Serve as Global Regulatory Lead for the Phase 3 HCM program, leading the development and execution of regulatory strategies that result in successful registration and post-approval commercialization of our HCM asset
- Provide strategic regulatory input and leadership at program governance forums and core team meetings
- Proactively identify regulatory risks and develop mitigation strategies
- Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness
- Serve as the primary point of contact with FDA and other health authorities as applicable
- Lead regulatory agency meetings and coordinate the preparation of supporting meeting materials
- Ensure the content in regulatory submissions is complete, well-written, and meets all applicable requirements for the program’s development phase
- Partner with and support Clinical, Nonclinical, CMC, and Safety & Pharmacovigilance activities, including the review and submission clinical protocols, IBs, DSURs throughout the product life cycle
- Ensure regulatory deliverables, support clinical timelines, quality standards, and compliance expectations
- Maintain broad and current knowledge of regulatory requirements and guidelines across clinical, nonclinical, submission, and compliance domains
- Support the implementation of additional systems and process improvements as needed.
Requirements
- Bachelor’s degree required; advanced degree in life science (MD, PhD, PharmD, or MS) preferred
- A minimum of 10 years of experience in regulatory affairs, including serving as Global Regulatory Lead for investigational products
- Hands-on experience with INDs and/or CTAs and writing regulatory documents
- Experience supporting Phase 3 development and late-stage regulatory activities
- Experience leading regulatory agency interactions and meetings
- Experience with marketing applications (e.g., NDAs/BLAs, MAAs) and post-approval supplements and variations is preferred
- Deep familiarity with cardiovascular or rare disease development program is a plus
- Thorough knowledge of US and international regulations as they apply to pharmaceutical drug development
- Demonstrated ability to communicate complex regulatory concepts clearly and effectively across internal and external stakeholders
- Strong strategic skills including demonstrated ability to make complex decisions and defend difficult positions
- Strong track record of strategic leadership, collaboration, and influence in cross-functional settings
- 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
- We are an equal opportunity employer.
- We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin.
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