ZymoGenetics, Inc.

Director, CMC Regulatory Affairs

Genes and t-shirts

Everything goes with discovery. At ZymoGenetics, we translate advanced genome database technology into breakthrough treatments for a range of human illnesses. Our 20-year history has given us a robust pipeline of product candidates advancing towards clinical development. With an IP portfolio of over 275 issued U.S. patents and over 500 foreign patents, ZymoGenetics is emerging as a leader in the biopharmaceutical industry. It’s creative work on the edge of computer and biological science. As for what you wear – that’s entirely up to you.

Location: Seattle, WA

The Director, CMC Regulatory Affairs is responsible for coordinating and preparing the CMC sections and follow-up responses for global applications (IND, CTA, CTX, BLA, NDA, MAA ), providing CMC support for global applications, assessing change control documentation, assisting in the development of regulatory strategies, and participating in project teams. The Director is accountable for the effective management of all regulatory activities associated with the global development, registration and maintenance of assigned ZymoGenetics, Inc. products. This position can serve as the primary regulatory liaison with development partners ex-US. The Director provides specialized knowledge/expertise, acts as primary liaison with the FDA and other regulatory agencies, and manages the process of fulfilling regulatory requirements associated with the clinical investigation and marketing approval of new products and continued support of marketed products.

The Director works independently in consultation with the Vice President, Regulatory Affairs on regulatory strategy for research, transition and development, and approved product development projects in order to shorten time to FDA approval, obtain the most favorable regulatory outcome, and provides timely updates on all projects to the VP. In addition, the Director is responsible for providing guidance to ZymoGenetics with regard to the regulatory requirements for compliance with current good manufacturing practices regulations in the U.S., and the European Union good manufacturing practices regulations. The Director may manage Regulatory Specialists in the preparation of global regulatory submissions.

REQUIRED SKILLS, EXPERIENCE & EDUCATION:

• BS degree (advanced degree preferred) in a related technical or scientific discipline.
• Significant experience in relating FDA regulatory requirements to CMC planning and product evaluation leading to FDA approvals; 10+ years of proven success in an FDA or EMEA-regulated industry with recent Drug or Biologic product approvals; in-depth knowledge of biologics CMC requirements, and the specific requirements for aseptic processing of biologic or pharmaceutical products. Prior experience in a reviewing division of the FDA is a plus.
• Knowledge of EU, Canadian, US, and ICH requirements for investigational drug development and post-approval compliance is a must.
• Ability to communicate effectively orally and in writing.
• Ability to function independently.
• Highly organized.
• Capable of supporting numerous projects simultaneously.
• Strong interpersonal and communications skills, collaboration/teamwork, and adaptive skills required.

Located in the historic City Light building on Seattle’s Lake Union, ZymoGenetics offers employment packages that include state-of-the-science challenges, flexible schedules, and a generous benefits package. For confidential consideration, visit the career page of our website to apply online at: www.zymogenetics.com or email: zymo@rpc.webhire.com. Please reference the Job Title and Zymo Source Code in the subject line. If including a cover letter, please place/paste after the resume. Or mail:

We are an equal opportunity employer and encourage applications from women and minorities.

ZymoGenetics, Inc.
Reference Job Code: Zymo-0354
Unit 247
Source Code Zymo-0354
P. O. Box 3175
Burlington, MA 01803
Email: zymo@rpc.webhire.com

ZymoGenetics, Inc. is an Equal Opportunity Employer

Submitted: 03/04/2006