AnorMED Inc.

Director of Regulatory Affairs

AnorMED is a biopharmaceutical company focused on the discovery, development and commercialization of new therapeutic products in the areas of hematology, HIV and oncology.

"One measure of success for any company is the extent to which it can make a positive impact on the world. What impact is AnorMED making? We are making a difference in the lives of people coping with cancer and HIV."

We are currently recruiting for the following position to help us make an impact.

Job Summary:

Reporting to the VP, Research and Development, the Director of Regulatory Affairs is responsible for overseeing all regulatory activities for the company.

Key Responsibilities include:

• Develops and implements regulatory development strategies for earliest possible approvals of clinical candidates.
• Oversees the preparation and filing of regulatory submissions, ensuring all appropriate regulatory activities are performed in support of on-going clinical studies.
• Liaises with clinical development to complete and submit SAE reports.
• Responsible for all safety filing including the Annual Report.
• Provides the outline and details for FDA NDA filing to project team and is responsible for document assembly and completion.
• Provides expert advice and analysis of regulations (clinical, manufacturing, etc.).
• Develops and maintains excellent communications/relationships within the FDA.
• Responsible for preparation for FDA audits and for the FDA visits.

Experience and Qualifications:

• Requires a master degree, a Ph.D., or a MD in a scientific discipline and a minimum of 5 years experience in Regulatory Affairs.
• Demonstrate knowledge of the drug development process in the U.S.
• Demonstrate knowledge of FDA and other regulatory agency’s drug and development requirements.
• Experience in preparation of regulatory submissions including but not limited to IND’s, Protocols, Safety Reports, and NDA’s.
• Experience in the primary communications role with the FDA.
• Excellent communication skills and interpersonal skills in company environment.

AnorMED offers competitive compensation, including stock options and a comprehensive benefits package.

We encourage you to apply online at www.anormed.com.

AnorMED Inc.
Attn: Human Resources
#200, 20353 64th Avenue
Langley, BC V2Y 1N5
Fax: 604-530-0976

AnorMED Inc. is an Equal Opportunity Employer

Submitted: 01/18/2006