Dir Labeling

As the U.S. subsidiary of a global pharmaceutical innovator, Daiichi Sankyo, Inc. draws on a rich heritage of innovation, integrity and accountability. While the success of our medicines speaks for itself, our corporate mission defines our vision and purpose: To enrich quality of life around the world through the development of innovative pharmaceuticals.

We currently have an opening for an Associate Director, Labeling in our Edison, NJ location. This position, under the direction of the Senior Director, will be responsible for preparing and updating labeling for new and existing products including Core Data Sheets, USPIs, and Medication Guides; and working with various groups within Daiichi Sankyo to ensure timely preparation and internal approval of these documents.

* Prepare regulatory documents (Drug Launch Labeling, US Prescribing Information, Annotated Labeling, Patient Insert, Medication Guide, Prescriber Brochure, Proprietary Name Requests, NDA Annual Report, Core Data Sheets) in paper and electronic format. Liaise and negotiate NDA labeling with FDA; strategize and plan for FDA meetings * Participate in global product team meetings (development and marketed products); provide regulatory support (IND/NDA, TPP process, INN Preparation, Drug Product Recalls) and guidance and manage day-to-day regulatory activities * Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. * Review and interpret regulatory guidelines. * Review RA and related documents for approval * Continuing Education: Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions.

**Education** * BS degree in chemistry, biology or other related scientific discipline required. * Masters or PhD preferred or equivalent experience **Experience** * 7+ years in the pharmaceutical industry. * 3+ years in global regulatory affairs.