Position: Regulatory Affairs
AIDSVAX Project Oversight Team

Introduction:
Global Solutions for Infectious Diseases (GSID) is a non-profit global health organization engaged in the development of diagnostic and preventive tools for infectious diseases, including HIV. The AIDSVAX B/E Project involves activities related to the development and production of AIDSVAX B/E vaccine for clinical use, including internal and CMO activities. The AIDSVAX Project Oversight Team is responsible for planning, coordination, implementation and management of activities and resources associated with project goals for this and other HIV vaccine projects. Responsibilities of each team member are based on the project goals related to his/her area of expertise.

Responsibilities:

• Manage all GSID regulatory systems and activities, including all interaction with regulatory agencies.
• Evaluate the regulatory situation of CMOs and other vendors.
• Develop and implement strategies for earliest possible approval of Phase 1 through Phase 4 applications.
• Provide expertise in translating regulatory requirements into practical, workable plans for development and production of AIDSVAX.
• Coordinate and manage timely preparation of organized and scientifically valid submissions.
• Interact with CMOs to coordinate CMC section preparation.
• Identify and evaluate fundamental issues for Regulatory functional areas through assessment of intangible variables, and interact with executive level management to influence policy making.
• Participate in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.

Required Experience:

• B.S. or higher degree in scientific discipline (biochemistry, chemistry, etc)
• 10+ years Regulatory Affairs experience in biotechnology or pharmaceutical industry
• Extensive experience interacting with regulatory agencies, including FDA, EMEA, and others
• Hands-on experience developing, implementing, and managing regulatory strategies and submissions for vaccines (preferred) or other biologics
• Experience with regulatory strategy for product/process changes
• Working knowledge of CBER requirements for approval of vaccines
• Previous experience with Quality by Design (QbD) programs a plus

If you are interested, please send GSID your resume.

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