Senior Director, Regulatory Affairs - Ellicott City, MD

TEAMWORK The Ultimate Symbiotic Relationship Focusing on a common goal. Performing your job accurately so that the next person can do theirs. That's how we work together at ICON Clinical Research. Because at ICON, your personal best is the valuable link in the teamwork we need to achieve quality results.Working with ICON, you'll share in a unique culture of a large company that emphasizes a warm, friendly environment. This is where career possibilities can become realities... where those who look for challenges, embrace the learning and growth opportunities we offer.ICON Clinical Research is dedicated to providing the pharmaceutical and biotechnology industries with exceptional clinical research and biometrics services, and we're the first international CRO awarded ISO 9001:2000 quality certification across all divisions and functions.
Senior Director, Regulatory Affairs
Ellicott City, MDThe selected candidate will be responsible for preparing and critiquing regulatory submissions such as INDs (clinical trials applications), full CTDs/NDAs, supplements, FDA meeting and planning strategy, as well as provide extensive strategic planning for regulatory issues related to drug development at all stages. In this role, you will review and sign-off of all regulatory submissions, for those projects designated as RA agent by client; review such submissions prepared by direct reports who are junior level personnel; and serve as liaison with FDA and/or other Agencies as requested by client. Additionally, IDS Sr. Management in defining and developing efficient internal systems for sharing and archival of strategic documents such as guidance and training programs; provide staff development as needed which includes hiring and supervision of direct reports and mentoring of junior staff members; work with internal Business Development to attract new clients for RA business. The medical writing and publishing group reports to this position.The qualified candidate will have a Master's Degree (or equivalent) in Biomedical Science, and at least 10 years of experience. Must also possess good interpersonal skills and technical judgment, attention to detail, and ability to work independently. Experience with strategic preparation for FDA meetings required. Must also have extensive experience in regulatory writing.
Job Requirements
Come to ICON and be an important part of a well respected and growing company that believes the details of your career are every bit as critical as the work you do. You'll enjoy highly competitive benefits in addition to flexible scheduling, relocation assistance, tuition reimbursement, credit union, health club privileges, and many other exceptional advantages.TO APPLY and for more information on our opportunities and locations, please visit us at