Director, Regulatory Affairs – Regenerative Medicine & Biologics Quality

IQVIA • Washington, DC

5d • $128,800 - $358,800

About The Position

The Director, Regulatory Affairs is a critical team member supporting regulatory strategy and submissions for client companies. The role manages regulatory submission development, overall regulatory strategy, communications with regulatory bodies and clients, and development of new therapy areas as applicable. Projects may span MCRA therapeutic areas and other areas of regulatory and scientific expertise. The Director also manages personnel across projects and mentors and trains junior employees.

The Director develops and executes regulatory services, manages staff and client projects, contributes to business development, and helps guide the regulatory department and company. The position works directly with client companies and regulatory bodies, provides project leadership, and collaborates with clinical, reimbursement, quality assurance, and other teams.

Requirements

• Bachelor’s degree in a scientific, engineering, or regulatory discipline.
• At least five years of Regulatory Affairs experience related to FDA oversight of human medical products, including HCT/Ps, drugs and/or biologics, medical devices, and combination products, with experience developing regulatory deliverables and submissions.
• Project management and/or managerial experience.
• Understanding of FDA regulations, clinical development, and data analysis.
• U.S. and/or international regulatory experience and fluency with regulations, standards, and guidance documents, such as FDA, ICH, and ISO.
• Regulatory expertise in regenerative medicine or another MCRA area of regulatory and scientific expertise.
• Understanding of the team's regulatory landscape, including its products and services, how they interact, and how data flows between deliverables.
• Strong attention to detail and ability to work independently, with multidisciplinary teams, and with external partners and vendors.
• Strong written, medical/technical writing, verbal communication, and presentation skills.
• Multidisciplinary understanding of engineering and biological sciences to support nonclinical and clinical strategies and communicate them effectively.
• Ability to develop and clearly document creative solutions.
• Strong research, analytical, critical-thinking, and problem-solving skills.
• Professionalism in customer relations and client relationship management.
• Ability to lead a team, mentor junior team members, and support team utilization targets as required.
• Ability to lead multiple projects with competing deadlines, take initiative and ownership, and demonstrate accountability.
• Strong organization and prioritization skills, with the ability to handle multiple tasks and meet deadlines independently.
• PC and technical skills, including MS Office, Excel, Word, and PowerPoint.
• Punctual, polished, and professional conduct.
• Effective interpersonal skills, confidence in subject matter, and a calm-under-pressure approach.

Nice To Haves

• Master’s or PhD degree.
• Knowledge and experience using research evidence and providing statistical analysis.

Responsibilities

• Develop and execute regulatory services for client companies, including regulatory submissions such as IND, BLA, pre-RFD, 510(k), IDE, PMA, and Technical Documentation.
• Manage regulatory agency interactions, including INTERACT, PDUFA meetings, and Q-Submissions.
• Develop regulatory strategy, analysis, and related deliverables.
• Assess product classification and jurisdiction.
• Manage Regulatory Affairs staff, facilitate their professional development, and ensure projects are completed accurately and on time.
• Lead and manage business development activities to secure new clients and projects.
• Develop project and departmental budgets and timelines as required.
• Work directly with client companies and regulatory bodies without oversight.
• Provide project leadership while maintaining the client relationship.
• Lead people development projects in collaboration with team managers as required.
• Collaborate with MCRA departments, including clinical, reimbursement, and quality assurance.
• Work with department heads and executive management to guide the development of the regulatory department and company.

Benefits

• A range of health and welfare benefits may be offered.
• Incentive plans, bonuses, and/or other forms of compensation may be offered depending on the position.

What This Job Offers

• Job Type: Full-time
• Career Level: Director