Targeted Genetics Corporation

Regulatory Affairs Associate

“We discover, develop and deliver molecular medicines to cure disease.”

Targeted Genetics Corporation is a Seattle-based biotechnology company developing gene therapy products for the treatment of acquired and inherited diseases. We are adding motivated professionals to capitalize on our leadership position in the field.

The TGC Regulatory Affairs group is recruiting for an experienced RA Associate. This position will:

• Coordinate and compile submissions to regulatory authorities in compliance with FDA, NIH and ICH guidelines and regulations.
• Work with management and project teams to provide input on regulatory requirements.
• Stay abreast of regulatory developments pertaining to biopharmaceutical and gene therapy product development.
• Represent the company in interactions with regulatory agencies.

Specific responsibilities may include:

• Preparing, compiling and filing documents including INDs, BMFs, IND amendments and Annual Reports to the FDA.
• Participating as a TGC representative in FDA interactions such as teleconferences, meetings, etc.
• Preparing and filing submissions and annual reports to the NIH RAC.
• Preparing regulatory documents to support international submissions.
• Providing regulatory compliance guidance to TGC personnel.

The successful candidate must work effectively in a fast paced environment and balance multiple priorities. Work must comply with regulations and TGC standards. Requires a Bachelors degree in a life-science discipline (or equivalent experience) and prior regulatory experience in a biotech or pharmaceutical setting. Strong word processing and document compilation skills are required.

For more information on other opportunities at Targeted Genetics Corporation visit our website at www.targetedgenetics.com. For consideration, please send your resume to:

Targeted Genetics Corporation
Attn: Human Resources
1100 Olive Way, Suite 100
Seattle, WA 98101
Fax: 206-521-4782
Email: careers@targen.com

Targeted Genetics Corporation is an Equal Opportunity Employer

Submitted: 03/20/2006