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

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November 24

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Clinton Health Access Initiative, Inc.

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Healthcare Insurance • Non-profit • Pharmaceuticals

Clinton Health Access Initiative, Inc. (CHAI) is a nonprofit global health organization committed to building a world where everyone has access to healthcare. Founded in 2002, CHAI focuses on tackling major health issues like infectious diseases, maternal and child health, and non-communicable diseases through various programs in over 35 countries. By partnering with governments and organizations, CHAI aims to reduce the cost of healthcare, enhance health policies, and improve health systems, ultimately saving lives and fostering a healthier future.

1001 - 5000 employees

Founded 2002

⚕️ Healthcare Insurance

🤝 Non-profit

💊 Pharmaceuticals

📋 Description

• Lead and manage product development initiatives, focusing on creating high-quality, cost-effective solutions that meet regulatory requirements and industry standards • Develop and implement regulatory strategies that ensure compliance with international standards, guiding partners and stakeholders through complex regulatory environments • Establish best practices for quality assurance and conduct comprehensive assessments to identify and address gaps in product quality • 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 • Oversee project planning and execution, ensuring alignment with organizational goals and timely delivery of results • Collaborate with cross-functional and cross-cultural teams to integrate PQCRA efforts with broader organizational objectives, fostering a culture of innovation and continuous improvement • 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

🎯 Requirements

• 7-12+ 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 Master's or PhD • General experience in PQCRA's focal areas, including product development, quality, and regulatory affairs, with desired experience in oral solid and sterile products • Demonstrated capacity to synthesize data into an effective presentation of results for a variety of audiences • Exceptional 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 • Highly proficient project management skills-ensures achievable project plans are in place and integrated with other team priorities • Excellent work ethic and flexibility • Highly motivated, independent, dynamic, and entrepreneurial thinker with strong managerial experience and interpersonal skills • Strong program management skills-ability to demonstrate high performance conceiving, planning, and executing on complex programs in unstructured and demanding environments without extensive operational support. • Proven experience as a strong leader, as well as team player, with an ability to mentor others for consistently high performance • Strong strategic thinker-ability to think creatively around long-term program objectives and the detailed steps necessary to achieve these goals • Ability to multitask and to be effective in high-pressure situations, and able to adapt to fast-paced and changing environments, both internally and externally • Ability to work independently on complex projects and solve challenging problems with limited structural or operational support • Fluency in English required, multilingualism advantageous to the applicant.

🏖️ Benefits

• CHAI is an Equal Opportunity Employer • Committed to providing an environment of fairness and mutual respect • Values diversity and inclusion