Attorney, Sr - Regulatory

Description Reporting directly to the Vice President, Associate General Counsel and head of the Corporate/Commercial/Compliance Group, the Senior Regulatory Counsel will provide proactive legal analysis and strategic advice to Regulatory Affairs and the Research and Development Organization and act as a strategic legal partner to the Senior Vice President of Regulatory Affairs pertaining to Food and Drug Administration (FDA) regulations, foreign ministries of health regulations and other laws and regulations pertaining to the research, development, approval and safety of pharmaceuticals and medical devices. In addition to providing strategic advice, the Senior Regulatory Counsel will provide guidance in the review of promotional and marketing materials, contract reviews and negotiations in connection with the companys business initiatives as relates to regulatory matters. In addition, this position will review and draft policies and procedures relating to regulatory requirements and participate in training relating to regulatory matters. Position Requirements Excellent law school credentials, state bar member and a minimum of 8 to 12 years of progressive FDA regulatory experience working in a large law firm, government agency or corporate legal affairs department are required; international regulatory experience is desirable. Excellent communication skills, attention to detail, responsiveness, diverse contracts and FDA experience are required. Apply for this Job