Dr. Yasmine Maher El-Shebiny
Regulatory Affairs expert with 14 years of solid Regulatory Affairs background in the pharmaceutical industry.
Profile and Areas of Expertise:
Experienced in developing different regulatory strategies in-line with business needs, leading registration, and lifecycle maintenance plans. In addition to safety management, compliance, SOPs design and audit readiness. Managed different lifecycle stages of an organization (merger, integration, and spin-off).
Drive interactions with Health Authorities, influence regulatory reforms and shape the external regulatory environment and health care policies.
Aspired to drive processes enhancements (Lean Six Sigma green belt certified). Have led and been a team member of different successful cross-functional projects including but not limited to New Product Launches, CMC and Ancillary component management, Safety management and Digital transformation in pharmaceutical industry.
Respect and leverage human capital – Motivate, coach, mentor and lead talented professionals helping teams to reach high integrated performance.