NeoRx Corporation

Senior Regulatory Affairs Specialist

NeoRx, a publicly traded biotechnology company, is a cancer therapeutics company developing products for targeted delivery of anti-cancer agents, including radiopharmaceuticals, to tumor sites has an immediate need for a Sr. Regulatory Affairs Specialist to insure that the development process meets FDA's Regulations and the Company's business goals and ensure the most expeditious Regulatory approval process.

Responsibilities include:

• Coordination and preparation of document packages for regulatory submissions ensuring compliance with the FDA regulations/interpretations. This may include the review, evaluation, and compilation of files and reports for submissions.
• Provide project team representation and direction in managing information from/to other departments including R&D;, Manufacturing, Quality Assurance, Quality Control, and Medical/Clinical. This may include the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments.
• Participate in the preparation and submission of INDs, IND amendments, responses to inquiries from regulatory agencies, and other submissions necessary to initiate and maintain clinical studies.
• Review technical and clinical documentation and recommends changes for labeling, manufacturing marketing, and clinical protocol for regulatory compliance.
• Research and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration.
• Timely completion of regulatory projects and submission of documentation to regulatory agencies. Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes.
• May provide regulatory guidance to project teams and other department staff.

Candidates must have BS/ MS degree in a scientific discipline or equivalent with a minimum of 5-8 years regulatory affairs experience in the development of biological or pharmaceutical products, the ability to handle multiple priorities, attention to detail and a high level of accuracy with excellent time management skills. Must have good PC skills, excellent verbal and written communication skills and demonstrate a familiarity with applicable sections of FDA laws.

NeoRx offers a competitive salary and excellent benefits. Please forward your resume with a cover letter in strict confidence to:

NeoRx Corporation
Human Resources
300 Elliott Avenue West, Suite 500
Seattle, WA 98119
Fax: 206-284-3181
Email: HR@neorx.com

NeoRx Corporation is an Equal Opportunity Employer

Submitted: 03/16/2004