Reedisha Gullapalli

About Reedisha Gullapalli

Progressive, professional growth as a strategic system thinker and organizational leader in biotech industry. Proven success in adapting and working within complex environments, leading teams that advance innovative technologies from early research to clinical trials and beyond.MY HIGHLIGHTS- Ability to adapt to evolving regulatory landscapes, quickly grasp new guidelines, and apply them effectively in regulatory affairs practices- Sound understanding and application of regulations (FDA, 21 CFR part 803 Medical Device Reporting and part 820.198EMA, WHO, ISO, NRA, ICH, CMC, cGMP, GCP, GVP) in drugs, medical devices, and biologics- In-depth knowledge of pharmaceutical, medical device, and biotechnology industries, including regulatory challenges and advancements.CORE COMPETENCIES:Process Improvement | Clinical Trial Support | Cross-Functional Collaboration | Compliance Metrics | Reporting and Documentation | Regulatory Compliance | Vendor Management | Case Assessment | Team Leadership | SOPs | SMPs | Stakeholder Relations | Medical Device Reporting | Project Management | Internal and Stakeholder Training | CAPAs | Database Management

Experience

1. Clinical Consent Senior Specialist

   Moderna

   Oct 2024 — Present

Education

• Northeastern University

  Master of Science - MS, Regulatory Affairs

• Punyashlok Ahilyadevi Holkar Solapur University, Solapur

  Bachelor's degree, Pharmacy