Head Of Research & Development

APEX Pharma

Lead R&D for pharmaceuticals, ensuring GMP compliance.

• Oversee product development, pilot batches, validation, and stability studies (ICH Q1).
• Apply Quality by Design (QbD) and risk management (ICH Q9) in product development.
• Prepare regulatory documentation and submissions (CTD/eCTD) for approval.
• Coordinate with QA, QC, and Production for technology transfer and scale-up.
• Lead and oversee all research and development activities to drive innovation in pharmaceutical product pipelines.
• Develop and implement R&D strategies aligned with organizational goals and regulatory requirements.
• Manage researchers, scientists, and developers to ensure project milestones are met.
• Coordinate cross-functional collaboration between research, regulatory, and production departments.
• Monitor industry trends, technologies, and competitor activities to inform R&D initiatives.
• Ensure compliance with pharmaceutical regulations and quality standards.
• Allocate resources, manage budgets, and optimize processes for efficient project execution.
• Oversee the preparation and submission of technical documentation, patents, and regulatory filings.
• Mentor and develop team members, fostering a culture of continuous learning and scientific excellence.
• Ensuring audit readiness and adherence to internal policies.