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| Associate Director Regulatory NY Open (J#39483) Title: Associate Director Regulatory Company: Progenics Pharma Job Summary Location Tarrytown, NY 10591 Industries Biotechnology/Pharmaceuticals Job Type Full Time Employee Years of Experience 7 to 10 Years Education Level Bachelor's Degree Career Level Manager (Manager/Supervisor of Staff) Job Reference Code 264 Associate Director Regulatory Affairs About the Job Reporting to the Director, RA, the successful candidate will direct and prepare documentation in accordance with the highest regulatory standards for submission to regulatory agencies, with an emphasis on US FDA in the small molecule area. This person will be detail-oriented and will have a solid working knowledge of cGLP, cGCP cGMPs, and eCTD NDA experience in regulatory affairs. The candidate should be a proven leader with the ability to establish regulatory policies and strategies in full compliance with all applicable regulatory requirements. He/she will serve as the regulatory representative on relevant project teams, and as the regulatory contact with FDA for small molecule projects, as needed. The Associate Director, RA will manage submission activities for assigned projects by collecting, preparing, reviewing and assembling documentation, as necessary, for new INDs, IND amendments, annual reports, meeting briefing packages and NDA submissions and supplements. The Associate Director, RA should be able to work in a small company environment and therefore must be facile and adept at balancing work. He/she should possess a solid knowledge of current regulatory requirements and ensure that changes in regulatory requirements that can affect the company s business are appropriately communicated to project teams and senior management. He/she will coordinate effectively with appropriate functional groups in identifying and obtaining documentation and information for regulatory submissions in a timely manner. The Associate Director, RA, will work with contractors and consultants, as needed. The candidate will be expected to develop and manage regulatory timelines as well as have the ability to multi-task. This person will also assist in the daily departmental activities by assigning and monitoring the work of staff in the small molecule area. Interacting with Clinical Research, Preclinical Development and other functional groups to ensure regulatory compliance is essential. Experience in eCTD NDA requirements and post-marketing activities is required and essential. Experience in antibodies, vaccines or gene therapy is desirable, but not essential. More... | |||
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