Regulatory Affairs Expert | 15+ Years of Industry Experience

Profile & Areas of Expertise:

With over 15 years of experience in Regulatory Affairs within the pharmaceutical industry, Dr. Yasmine Maher El-Shebiny specializes in developing regulatory strategies tailored to business objectives. She leads comprehensive registration and lifecycle maintenance plans, oversees safety management and compliance, and designs SOPs with a focus on audit readiness. Her expertise spans various phases of organizational transformation, including mergers, integrations, and spin-offs.

Key Achievements:

• Health Authority Engagement & Regulatory Reform Advocacy: Dr. El-Shebiny has built productive relationships with Health Authorities, influencing regulatory reforms and shaping healthcare policies effectively.
• Process Enhancement & Project Leadership: A Lean Six Sigma Green Belt certified professional, she is dedicated to optimizing processes and has successfully led cross-functional projects, including new product launches, CMC and ancillary component management, safety management, and digital transformation within the pharmaceutical landscape.
• Team Development & Leadership: Dr. El-Shebiny is committed to fostering a high-performance culture, mentoring, coaching, and leading diverse teams to drive integrated performance and leverage human capital for outstanding results.