• 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