Director, Regulatory Affairs – Regenerative Medicine & Biologics Quality

IQVIA•Washington, DC

About The Position

The Director, Regulatory Affairs is a critical team member supporting regulatory strategy and submissions for client companies. The role manages development of regulatory submissions, creates overall regulatory strategy, communicates with regulatory bodies and clients, and may lead or expand work in new therapeutic areas. Projects may involve MCRA therapeutic areas and other areas of regulatory and scientific expertise or growing therapeutic concentrations. The Director manages personnel across projects and mentors and trains junior employees. The Director develops and executes regulatory services, oversees regulatory staff and project delivery, leads business development to secure clients and projects, and develops project or departmental budgets and timelines as needed. The role works directly with clients and regulatory bodies, provides project leadership and client relationship ownership, and collaborates with internal departments and executive leadership to support the regulatory department and company.

Requirements

Bachelor’s degree in a scientific, engineering, or regulatory discipline; a master’s or Ph.D. is preferred.
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, or combination products, and 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 products, services, how they interact, and how data flows between deliverables.
Strong attention to detail and ability to work independently, on 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 to internal team members and clients.
Ability to develop creative solutions and communicate them clearly in writing.
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 the team in reaching target utilization, as required.
Ability to lead multiple projects with competing deadlines, take initiative and ownership, and demonstrate self-accountability.
Excellent organizational and prioritization skills, with the ability to manage multiple tasks and deadlines independently.
PC and technical skills, including MS Office, Excel, Word, and PowerPoint.
Punctual, polished, and professional demeanor.
Effective interpersonal skills, confidence in subject matter, and a calm-under-pressure approach.

Nice To Haves

Master’s or Ph.D. 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 product classification and jurisdiction recommendations.
Manage Regulatory Affairs staff, facilitate 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 sole relationship with client companies.
Lead people-development projects with team managers, as required.
Collaborate with other MCRA departments, including clinical, reimbursement, and quality assurance.
Work with department heads and executive management to guide the progress and development of the regulatory department and company.
Mentor and train junior employees.