Archana Reddy, MPH, MS
Regulatory Consultant @ Independent Consultant
About
My career has been defined by leading at the at the intersection of science and regulation while staying grounded in a lifelong commitment to equity and public health. Resilience, ethics, and integrity are the cornerstones of my life journey, unafraid to advocate for truth and accountability and challenge the status quo. I bring a global perspective to science, health, and policy. It began in 1998, when during my graduate studies at Columbia I worked with Aboriginal women in Australia to launch a healthy lifestyles program. That foundation carried me into a 27‑year career spanning service at the FDA, leadership of Regulatory Affairs teams and departments, and work as an expert consultant guiding biotech companies through global strategy and compliance. Along the way, I’ve also navigated startup accelerators, continually shaping ideas into action Today, inspired by my grandfather’s legacy in education, I’m channeling my regulatory and biotech experience into science education and edtech. My mission is to transform how knowledge is delivered, ensuring that science becomes more accessible, equitable, and impactful for the next generation. Areas of expertise: Regulatory Strategy| FDA & Global Submissions |Regulatory Compliance| Biotech Innovation |Public Health Advocacy| Policy & SOP Development| Regulatory Intelligence| Business Development & Proposal Writing| Team & Department Leadership| Science Education| EdTech Development| Equity in science IND|NDA|CTA|MAA|Labeling|FDA meetings Orphan|Rare disease|Combination|Small molecules|Biologics Therapeutic Areas: Women’s Healthcare|Urology|Oncology|Medical Imaging, Neurology|Endocrine|CKD|HIV Prevention|Cardiovascular|Metabolic|Microbiome and EUA for Covid Start-up Accelerators: Wharton Accelerator & CAI Languages: Fluent in Spanish & Elementary Japanese Open to transparent, ethical, and value based partnerships and collaboration at the intersection of science, public health, and regulations.
United States
Washington DC-Baltimore Area
Pharmaceuticals
Artificial Intelligence (AI), Regulatory Interactions, Regulatory Guidelines, Development Programs, Adobe Acrobat, Research Skills, CTA, Approval Process, Small Molecules, Conflict Resolution, Documentation Practices, Strategic Development, Marketing Authorisation Application (MAA), Cell Therapy, Regulatory Agencies, Team Management, Pharmaceuticals, Team Leadership, Business Development, Executive Coaching
Experience

Senior Director, Regulatory Affairs (Consultant)
Employvision Inc.; Randstad Health Sciences
Worked as a RA Snr Director in a consulting capacity Responsible for managing programs for the US as well as a team of consultants at one company Responsible for client deliverables and oversight as well as strategy

Director of Regulatory Affairs
Washington DC-Baltimore Area
Served as a in-house Director of RA Consulting for a CRO specializing in clinical trials Responsible for client deliverables, proposals, and participating in bid defense meetings Regulatory strategic advice and submission oversight
Education

STEM
Graduate level courses in education 7/9 Masters level’s coursework completed with 3.76 GPA. Completed coursework in Learning Sciences, Intro to Special Education, Designing Effect Learning Tech, Secondary Methods of Teaching, Foundations Education, Methods Teach Science, and Teacher Research and Inquiry
Archana Reddy, MPH, MS's Contact Information
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