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Head Of R&D - Pharmaceutical

APEX Pharma
Badr City, Cairo
APEX Pharma logo

Head Of R&D - Pharmaceutical

Badr City, Cairoposted 28 days ago
44Applicants for1 open position
  • 7Viewed
  • 3In Consideration
  • 0Not Selected

Job Details

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Job Description

  • 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.

Job Requirements

  • Bachelor’s degree in Pharmacy, Pharmaceutical Sciences (Master’s/PhD preferred).
  • At least 15 years in pharmaceutical R&D, with at least 5 years in a managerial role.
  • Strong knowledge of GMP regulations, ICH guidelines (Q1, Q8, Q9), and regulatory submission processes (CTD/eCTD).
  • Experience with product development in pharmaceuticals and dietary supplements.
  • Strong understanding of pharmaceutical product development processes and regulatory frameworks.
  • Proven leadership skills with the ability to manage teams and collaborate cross-functionally.
  • Excellent Scientific capability, Innovation, Creativity, and Thinking out of the box.

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