APEX Pharma -
Company: APEX Pharma –
WebSite: Badr City, Cairo, Egypt
Job Description:The individual in question directs pharmaceutical Research and Development, ensuring compliance with Good Manufacturing Practices (GMP). Responsibilities encompass overseeing product development, pilot batch production, validation processes, and stability studies in accordance with ICH Q1 guidelines. The application of Quality by Design (QbD) principles and risk management strategies (ICH Q9) is integral to product development activities. This role also includes the preparation of regulatory documentation and submissions (CTD/eCTD) for approval by relevant authorities. Effective coordination with Quality Assurance (QA), Quality Control (QC), and Production departments is maintained to facilitate technology transfer and scale-up operations. The individual provides leadership and oversight for all research and development activities, driving innovation within the pharmaceutical product pipeline. Furthermore, they develop and implement R&D strategies aligned with organizational objectives and regulatory requirements. Management of researchers, scientists, and developers is undertaken to ensure project milestones are achieved. Cross-functional collaboration between research, regulatory affairs, and production departments is actively coordinated. The individual monitors industry trends, emerging technologies, and competitor activities to inform R&D initiatives. Compliance with pharmaceutical regulations and quality standards is consistently ensured. Resource allocation, budget management, and process optimization are undertaken to facilitate efficient project execution. Oversight of the preparation and submission of technical documentation, patent applications, and regulatory filings is also provided. Mentoring and development of team members is prioritized, fostering a culture of continuous learning and scientific excellence. Finally, ensuring audit readiness and adherence to internal policies is a core responsibility.
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