Director, Regulatory Affairs – Regenerative Medicine & Biologics Quality
IQVIA · Washington, DC
RegulatoryFull-time$135k–$377kCompany career page
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Role summary
IQVIA seeks a Director of Regulatory Affairs to lead regulatory strategy and submissions for regenerative medicine and biologics clients. The role combines regulatory expertise with team management, client relations, and business development within a consulting environment.
What they're looking for
- Bachelor's degree in scientific, engineering, or regulatory discipline; Master's or PhD preferred
- Minimum five years regulatory affairs experience with FDA-overseen medical products and submissions
- Project management and/or managerial experience required
- Domain expertise in regenerative medicine or related MCRA regulatory areas
- Proficiency with FDA, ICH, and ISO regulations and guidance documents
- Strong written and verbal communication, including medical/technical writing capabilities
- Demonstrated ability to lead teams, mentor junior staff, and manage multiple competing projects
What you'll be doing
- Develop and execute regulatory submissions including INDs, BLAs, 510(k)s, PMAs, and technical documentation
- Manage regulatory agency interactions and strategy development; lead Q-submissions and PDUFA meetings
- Direct regulatory affairs staff, oversee project completion, and facilitate professional development
- Maintain direct client relationships, provide project leadership, and manage business development activities
- Collaborate cross-functionally with clinical, reimbursement, and quality assurance departments
Privacy & handoff
This role links to IQVIA's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.