Senior Technical Manager, Product Development, Quality, Costing, and Regulatory Affairs

divh2Senior Technical Manager / h2pThe 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. We work at the invitation of governments to support them and the private sector to create and sustain high-quality health systems. / ppCHAI was founded in 2002 in response to the HIV / AIDS epidemic, with the goal of dramatically reducing the price of life-saving drugs and increasing access to these medicines in the countries with the highest burden of the disease. Over the following two decades, CHAI has expanded its focus. Today, along with HIV, we work in conjunction with our partners to prevent and treat infectious diseases such as COVID-19, malaria, tuberculosis, and hepatitis. Our work has also expanded into cancer, diabetes, hypertension, and other non-communicable diseases, and we work to accelerate the rollout of lifesaving vaccines, reduce maternal and child mortality, combat chronic malnutrition, and increase access to assistive technology. We are investing in horizontal approaches to strengthen health systems through programs in human resources for health, digital health, and health financing. With each new and innovative program, our strategy is grounded in maximizing sustainable impact at scale, ensuring that governments lead the solutions, that programs are designed to scale nationally, and learnings are shared globally. / ppAt CHAI, our people are our greatest asset, and none of this work would be possible without their talent, time, dedication, and passion for our mission and values. We are a highly diverse team of enthusiastic individuals across 40 countries with a broad range of skill sets and life experiences. CHAI is deeply grounded in the countries we work in, with the majority of our staff based in program countries. / ppCHAI is an Equal Opportunity Employer, and is committed to providing an environment of fairness, and mutual respect where all applicants have access to equal employment opportunities. CHAI values diversity and inclusion, and recognizes that our mission is best advanced by the leadership and contributions of people with diverse experience, backgrounds, and culture. / ph2Responsibilities / h2ullistrongProduct Development Leadership : / strong Lead and manage product development initiatives, focusing on creating high-quality, cost-effective solutions that meet regulatory requirements and industry standards. / lilistrongRegulatory Strategy : / strong Develop and implement regulatory strategies that ensure compliance with international standards, guiding partners and stakeholders through complex regulatory environments. / lilistrongQuality Assurance : / strong Establish best practices for quality assurance and conduct comprehensive assessments to identify and address gaps in product quality. / lilistrongStakeholder Management : / strong Build and maintain strong cross-cultural relationships with key stakeholders, including pharmaceutical manufacturers, regulatory bodies, and healthcare organizations, to support product development and market introduction. / lilistrongProject Management : / strong Oversee project planning and execution, ensuring alignment with organizational goals and timely delivery of results. / lilistrongTeam Collaboration : / strong Collaborate with cross-functional and cross-cultural teams to integrate PQCRA efforts with broader organizational objectives, fostering a culture of innovation and continuous improvement. / lilistrongTechnical Expertise : / strong Provide technical guidance and support for bioequivalence studies, pharmacokinetics / pharmacodynamics analyses, manufacturing processes, synthetic chemistry, sourcing and costing analyses, and clinical trials to evaluate product safety and efficacy. / li / ulh2Qualifications / h2ulli7-12+ years of experience in the pharmaceutical / biotechnology industry and / or a pharmaceutical regulatory agency is required. Experience in a results-driven environment, with increasing levels of responsibility and leadership. Preference will be given to candidates with a Masters or PhD. / liliGeneral experience in PQCRAs focal areas, including product development, quality, and regulatory affairs, with desired experience in oral solid and sterile products. / liliDemonstrated capacity to synthesize data into an effective presentation of results for a variety of audiences. / liliExceptional diplomatic and communication skills, especially in cross-cultural settings, and the ability to collaborate effectively with a wide range of partners and stakeholders across sectors. / liliHighly proficient project management skills-ensures achievable project plans are in place and integrated with other team priorities. / liliExcellent work ethic and flexibility. / liliHighly motivated, independent, dynamic, and entrepreneurial thinker with strong managerial experience and interpersonal skills. / liliStrong program management skills-ability to demonstrate high performance conceiving, planning, and executing on complex programs in unstructured and demanding environments without extensive operational support. / liliProven experience as a strong leader, as well as team player, with an ability to mentor others for consistently high performance. / liliStrong strategic thinker-ability to think creatively around long-term program objectives and the detailed steps necessary to achieve these goals. / liliAbility to multitask and to be effective in high-pressure situations, and able to adapt to fast-paced and changing environments, both internally and externally. / liliAbility to work independently on complex projects and solve challenging problems with limited structural or operational support. / liliFluency in English required, multilingualism advantageous to the applicant. / li / ul / div