Associate Director, Regulatory Affairs Avid Radiopharmaceuticals
THIS JOB HAS EXPIRED Reports To: Senior Director, Regulatory Affairs
Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly owned subsidiary of Eli Lilly and Company, is an emerging molecular imaging company developing novel PET imaging agents with the potential to aid in diagnosis, treatment selection and therapeutic monitoring of serious diseases including Alzheimer?s disease, Parkinson?s disease and diabetes. Avid?s lead compound, the ?-amyloid imaging agent florbetapir F 18, has been approved by the FDA. For more information, visit www.avidrp.com.
This position is responsible for carrying out Avid?s regulatory affairs plans and programs in support of medical imaging drug development as well as corporate compliance with regulations applicable to company operations (e.g. US FDA, USDA, NRC). The individual works closely with other R&D management of the company to implement regulatory strategy, supporting the establishment of project and program plans and precise timelines, and manage and monitor the completion of all regulatory activities associated with new drug development programs.
The individual reports to the Senior Director of Regulatory Affairs, and will interface with Research, Product Development, Clinical Development, and Project Management departments regarding the preparation and filing of regulatory submissions, as well as project goal setting, timeline development and monitoring. The responsibilities of the individual in this position include:
?In close cooperation with R&D management team members, establishing and implementing regulatory goals for all development programs of the company
?Preparation and filing of INDs, IND amendments and other regulatory submissions, and working closely with administrative support and functional leaders of the company to produce high quality submissions
?Working closely with project management to create detailed multi-disciplinary project timelines and monitoring and reporting progress against timelines to the senior management of the company.
?Identifying and anticipating and regulatory and project development risks and making recommendations to senior management regarding alternatives for risk mitigation
?Working closely with other departments to assure that necessary Standard Operating Procedures are in place for the critical drug development activities of the company and our external CRO or CMO partners
Education and Experience:
?An advanced degree in a scientific discipline relevant to drug discovery and development
?At least 7 years of regulatory affairs experience in a corporate drug development organization
?Experience in medical imaging drug development and/or radiopharmaceuticals preferred; previous direct interaction with medical imaging division of FDA is strongly preferred
?RAC certification a plus
?CMC regulatory affairs proficiency a plus
?Strong interpersonal skills
?Project management skills and familiarity with project planning and software tools
?Strong computer skills including MS Office (Word, Excel, PowerPoint, Acrobat)
?A high level of familiarity and understanding of FDA regulations and guidelines related to drug development (GLP, GMP and GCP)
||3624 Market |
Philadelphia, PA 19104
THIS JOB HAS EXPIRED