Aysha Rana

About Aysha Rana

Greetings! I\'m Aysha, a seasoned Regulatory Affairs professional with a Master\'s in Regulatory Affairs at one of the top university, Northeastern University, Boston, USA and a strong foundation (Doctors of Pharmacy) from Punjab University, Pakistan. Currently I am working for the regulations of Medical devices (Capstone Project) at Spectra Medical Company in Boston, MA-I commenced my career in Regulatory Affairs at Remington Pharma, where I contributed to both domestic and international projects. Pioneered the WHO Prequalification process-Throughout my professional journey, I\'ve held impactful roles at renowned organizations such as Genetics Pharmaceuticals and Pharmedic Labs, where I served as Manager Regulatory Affairs while managing the whole department-Notably, I led the Regulatory Affairs department (HOD)at Next Pharma, achieving significant milestones in projects with WHO, DRAP, MHRA, UNICEF-WHO, BfArm, and PIC/S-My expertise spans CMC, Pharmaceuticals, Neutracueticals, Biologicals, Medical Devices, and Consumer Health Products. I\'ve excelled in areas such as PSQCA registrations, PCSIR testing protocols, contract manufacturing, pricing, post variations, and quota allocation in Pakistan-My responsibilities include developing regulatory strategies, maintaining documentation, liaising with regulatory authorities, ensuring global compliance, and implementing robust pharmacovigilance systems-I\'ve played a pivotal role in regulatory submissions and obtaining registrations across ASEAN member countries, CIS, and others. I bring a wealth of knowledge in CTD/ACTD dossier compilation, and comprehensive regulatory oversight. Are you seeking a results-driven regulatory affairs expert to elevate your team\'s performance and ensure regulatory excellence? Let\'s connect and explore synergies! 🤝

Experience

1. Regulatory Affairs Specialist-capstone

   Elevaris Medical Devices

   Jan 2025 — Present · US

   EU MDR 2017/745 compliance expertiseRegulatory strategy development and implementationDesign History File (DHF) review and gap analysisRisk management and clinical evaluation documentationTechnical writing and cross-functional team collaboration

Education

• University of the Punjab

  Doctor of Pharmacy - PharmD, Pharmacy

• Northeastern University

  Master's degree, Regulatory Affairs