Assistant Director, Regulatory Affairs

ASSISTANT DIRECTOR, REGULATORY AFFAIRSJOB ID #1184CLAYTON, NCTalecris Biotherapeutics is a global company that discovers, develops and produces critical treatments for people with life-threatening disorders. We'll inspire you to achieve your best, and give you the freedom to explore, innovate and grow. Bring your talents to us today in our current opening for an Assistant Director, Regulatory Affairs. This position is available at our manufacturing facility located in Clayton, NC.This position in the Regulatory Affairs Department product development group manages all aspects of the preparation of regulatory submissions including filing for orphan drug designation, IND, CTA Biologic License, and Marketing Authorization applications, and annual reports. You will also assist with projects such as life cycle management (new indications for existing products) and new product development; provide guidance and training to document authors as needed, and arrange for review, approval and publishing of the dossier; and negotiate and oversee contracts with external consultants as required. Qualifications: o Bachelor's degree in a biomedical science and a minimum of 8 yrs. experience in Regulatory Affairs, Quality, or a related area in the biological products, biotechnology, or pharmaceutical industry (or equivalent combination of education/experience) " Thorough understanding of the overall drug development and regulatory agency submission review process, preferably both in the U.S. and internationally" Knowledge of federal regulations and international standards (e.g. ICH,) as they pertain to product development (process development, preclinical studies and clinical studies) " Experience in device/combination product submissions and regulatory issues is highly desiredTalecris offers a competitive salary and benefit package including 401(k) vesting day one with company match, management bonus and profit sharing. All benefits take effect day one of employment. Recently voted to the Companies That Care, Talecris is proud of its work, life, balance programs and its generous tuition reimbursement program. Interested candidates may apply online: www.talecris.com (Refer to Job ID# 1184). (No phone calls or agency referrals, please). EOE M/F/D/V