Senior Regulatory Associate/Manager, 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.

To continue our legacy of excellence at ICON, GloboMax, a dynamic and innovative Product Development Organization committed to helping pharmaceutical and biotech companies bring products through development from early stage to regulatory approval, is now the Strategic Pharmaceutical Development Division of ICON.

Senior Regulatory Associate/ Manager, Regulatory Affairs
Ellicott City, MD

ICON Development Solutions

The selected candidate will manage the Regulatory Affairs activities including preparing, reviewing and authorizing regulatory submissions; and acting as a liaison with FDA and other agencies. Additionally, you will be act as a consultant in regard to regulatory aspects of drug development, protocols and clinical development programs and supervise regulatory affairs staff. You will also be responsible for business development functions including preparations of bids and proposals and acting as a client liaison; project management including resources, timelines and budgets; and staff development including hiring, supervising, performance appraisals and mentoring.

The qualified candidate will have a bachelor?s degree or higher along with a minimum of 3 years pharmaceutical/CRO experience. Experience with regulatory writing (NDA, IND, etc.), drug development and strategic FDA liaison activity in regulatory affairs; excellent written and verbal communication skills; and supervisory experience are required.





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 http://www.iconclinical.com/index.asp?getpage=true&sid=10 . No agencies, please.

ICON. We are the right solution.

ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity.

www.iconclinical.com
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