Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.    Job #02716 About our client Our client is a rapidly growing pharmaceutical company headquartered in the Midwest that is focused on the development and commercialization of therapeutic radio-pharmaceuticals for the US nuclear medicine market. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Director Regulatory Affairs Midwest, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Interpret directives, regulations and guidelines 2) Develop and implement strategies for electronic submissions 3) Assist in developing and executing global regulatory plans 4) Generate regulatory document, including pre-IND/IDE briefing documents, INDs, IDEs, end-of-Phase II briefing documents, CMC, clinical study reports, NDAs and PMAs (including integrated efficacy and safety summary documents) 5) Interact with senior-level management concerning significant regulatory matters to obtain services to support regulatory objectives 6) Represent Regulatory Affairs to other departments and provide guidance on adherence to regulatory guidelines for effective submissions 7) Maintain policies to ensure adherence to and compliance with all applicable FDA/ICH guidelines and with current GLP, GMP and GCP guidelines 8) Analyze trends and evaluate the impact of governmental regulatory activities 9) Build excellent relationships inside and outside the company 10) Create and revise SOPs governing regulatory operations activities Requirements 1) Bachelor’s degree 2) 7 – 10 years of experience 3) Experience in pharmaceutical quality assurance, quality control and regulatory affairs 4) Experience in oncology preferred 5) Good knowledge of Federal Food, Drug and Cosmetic Act (FD&C Act) 6) Superb knowledge of regulatory principles, especially relating to pharmaceutical development 7) Ability to transcend customary corporate boundaries
Home | Our Story | Domain Expertise | Clients | Career Opportunities | Community | Contact Us
© 2006 Sterling Life Sciences. All rights reserved. Terms of Agreement.