Senior Technical Manager, Product Development and Regulatory Affairs, R&D
Clinton Health Access Initiative
May 3, 2018
Durham, North Carolina
Full Time - Experienced
The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to saving lives and reducing the burden of disease in low-and middle-income countries, while strengthening the capabilities of governments and the private sector in those countries to create and sustain high-quality health systems that can succeed without our assistance. For more information, please visit: http://www.clintonhealthaccess.org.
CHAI is working with manufacturers of drug products to expand the product pipeline of low cost, high quality products. CHAI is also working with high-volume, early-adopter countries to overcome barriers that prevent adoption and scale-up, including regulatory hurdles and limited guidance on quality to build a healthy, competitive global market for these products, while negotiating with manufacturers to lower prices.
The Product Development Senior Technical Manager will work to support pre- and post- market drug products for diseases such as HIV/AIDS, tuberculosis, malaria, hepatitis, cancer, and child/maternal health in key resource-constrained markets. Several such products are currently available or are in development, with the potential to dramatically increase access to treatment, improve patient outcomes, and make healthcare systems more efficient.
The Product Development Senior Technical Manager will work across CHAI teams to develop strategies for overcoming key barriers related to product development, filing, approval, introduction and adoption. The Product Development Senior Technical Manager will be responsible for translating these strategies into actionable items, and managing relationships with manufacturers, partners, SRAs, NDRAs, Ministries of Health and other key stakeholders. Anticipated travel may be required up to 30%.
Serve as product development, quality and regulatory core team representative to CHAI teams and external partners for drug products, medical devices, and drug-device combination products
Work in a project-focused team environment with innovator and generic product manufacturers to develop project plans and strategies for formulation development activities
Support CHAI's quality and regulatory practices for drug products including best practices, tools, and templates to use across a variety of projects
Develop strong relationships with procurement partners, NDRAs, Ministries of Health, global health stakeholders such as clinical research centers and academic groups, and CHAI country teams to create and implement strategies for product development, market introduction and adoption of products for a variety of diseases that impact resource-constrained markets
Perform cGMP gap analyses and review regulatory submissions for new innovator and generic product manufacturers
Perform other responsibilities as requested by manager
An undergraduate or graduate-level technical degree with significant experience in product development and regulatory affairs
Minimum 5 years of private sector work experience, preferably in the pharmaceutical industry
Knowledge and experience with all facets of product development and regulatory requirements
Strong analytical, problem solving, and quantitative skills, and the ability to learn new skills quickly
Detail-oriented with strong organization skills and the ability to handle multiple work streams simultaneously and to work independently
Excellent written and verbal communication skills
Ability to think strategically, manage change, work efficiently, and communicate effectively on fast-paced and multicultural teams