Position Summary:

Are you an experienced Regulatory Affairs leader who’s eager to help bring vaccines and other cutting edge health solutions to market?  Join IAVI and help us translate science into global health solutions!

IAVI is seeking an experienced a Director or Senior Director of Regulatory Affairs to serve as a regional lead for clinical trials throughout Africa. The leader will support regulatory activities to help advance products to licensure. This leader will develop and implement regulatory strategies and manage submission processes for a portfolio of products of vaccines and biologics in development to treat HIV/AIDs, TB, and other emerging infectious diseases impacting lower- & middle-income countries.  The Sr. Director will also help improve and expand the capacity and infrastructure of IAVI regulatory affairs.

The Director (Or Senior) of Regulatory Affairs serves as a regional lead for IAVI sponsored clinical trials being conducted in Africa and supports regulatory activities to advance products to licensure. These trials could include different biological products being developed for the prevention and treatment of HIV/AIDS, emerging infectious diseases, TB, and other targets that are the focus of IAVI efforts.  The Director develops and implements regulatory strategies and manages the submission processes for a portfolio of products. The Director also supports ongoing activities to improve and expand the capacity and infrastructure of the Regulatory Affairs department.

Key Responsibilities:

• In collaboration with the global team, the incumbent will work to identify, develop, and utilize plans needed to support both early and later phase clinical trials of HIV vaccines and other experimental vaccines and/or biologics across various disease areas.
• Engagement with regulatory agencies to gain acceptance and concurrence for trials to be conducted in Africa.
• Serve as the primary point of contact with regulatory agencies for assigned projects in scheduling and leading meetings, maintaining communication, and responding to queries for active submissions.
• Work within the project team structure to support multi-national clinical trials ensuring a harmonized approach that is aligned with the overall product development strategy.
• Manage critical issues and identify required activities to ensure that regulatory submissions are accurate and appropriate and completed with the project timeline.
• Provide leadership and management of junior regulatory team members and consultants.
• Provide training and guidance to other department members in areas of expertise.
• Perform other tasks as assigned by the Executive Director.

Requirements

Education and Work Experience:

• MS or PhD in life sciences or related field is required.
• Minimum of 10 years’ experience (for Director) or minimum of 12 years’ experience for Senior Director, in regulatory affairs with related vaccine or biologics, including experience with regulatory authorities in sub-Saharan Africa.
• Experience in working with regulatory consultants and contract research organizations is required.
• Experience in working with regulatory agencies in West Africa is desirable.

Qualifications and Skills: 

• Excellent organizational skills are required.
• Excellent verbal and written communication skills are required and a good working knowledge of Microsoft Office applications.
• Knowledge and experience in the preparation of regulator dossiers for regulators in Africa.
• Knowledge of GMP, GLP, GCP and /or quality assurance and regulatory affairs associated with biological products is highly desirable.