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Clinton Health Access Initiative, Inc. · 1 month ago

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

United States

Full-time

Remote

Senior Level

7+ years exp

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. They are seeking a Senior Technical Manager to lead product development initiatives, develop regulatory strategies, and ensure quality assurance in healthcare solutions.

Health Care

Responsibilities

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

Qualification

Product DevelopmentRegulatory StrategyQuality AssuranceProject ManagementTechnical ExpertiseStakeholder ManagementCross-cultural CommunicationMultitaskingFluency in EnglishTeam CollaborationLeadershipProblem Solving

Required

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

General experience in PQCRA's focal areas, including product development, quality, and regulatory affairs

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

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

Preferred

Master's or PhD

Experience in oral solid and sterile products

Multilingualism advantageous to the applicant

Company

Clinton Health Access Initiative, Inc.

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CHAI's mission is to save lives and improve health outcomes in low- and middle-income countries by enabling the government and private sector to strengthen and sustain quality health systems.

Founded in 2002

Boston, Massachusetts, USA

1001-5000 employees