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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.



