Archana Reddy, MPH, MS

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.

Country

United States

City

Washington DC-Baltimore Area

Industry

Pharmaceuticals

Skill

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

Independent Consultant

Regulatory Consultant

Independent Consultant

LinkedIn
2025-2 - Present · 1 yr 8 mos
Actalent

Regulatory Affairs Consultant

Actalent

LinkedIn
2024-11 - 2025-1 · 3 mos
OncoBay Clinical (now Kapadi)

Senior Director, Regulatory Affairs

OncoBay Clinical (now Kapadi)

LinkedIn
2023-7 - 2024-8 · 1 yr 2 mos
Lumanity

Director of Regulatory Affairs

Lumanity

LinkedIn
2023-2 - 2023-7 · 6 mos
ICON plc

Director of Regulatory Affairs

ICON plc

LinkedIn
2021-8 - 2023-2 · 1 yr 7 mos
Employvision Inc.; Randstad Health Sciences

Senior Director, Regulatory Affairs (Consultant)

Employvision Inc.; Randstad Health Sciences

2021-2 - 2021-8 · 7 mos

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

Pharmaron Clinical Services

Director of Regulatory Affairs

Pharmaron Clinical Services

LinkedIn
2020-8 - 2021-1 · 6 mos

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

FootBridge Consulting

Consultant

FootBridge Consulting

LinkedIn
2019-10 - 2020-7 · 10 mos

Boston, Massachusetts, United States

Served a a Consultant at two different companies for programs in Alzheimer’s and microbiome Oversight of submissions and strategy Program management

Biocon

General Manager

Biocon

LinkedIn
2019-1 - 2019-5 · 5 mos

Bengaluru, Karnataka, India

Biocon

Director of Regulatory Affairs

Biocon

LinkedIn
2018-10 - 2018-12 · 3 mos

Washington DC-Baltimore Area

Caligor Coghlan

Director of Regulatory Affairs

Caligor Coghlan

LinkedIn
2018-4 - 2018-8 · 5 mos

Washington D.C. Metro Area

Education

Loyola University Maryland

Loyola University Maryland

LinkedIn

STEM

2025-5 - 2025-12 · 8 mos

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

Purdue Global Law School

Purdue Global Law School

LinkedIn
2015 - 2016 · 1 yr

Completed first year law school course work and initiated second year.

Vanderbilt University

Vanderbilt University

LinkedIn

Chemistry/Spanish

Columbia University

Columbia University

LinkedIn

Health Policy

The Johns Hopkins University

The Johns Hopkins University

LinkedIn

Biotechnology

Archana Reddy, MPH, MS's Contact Information

Email

******@***.com

Phone

(**) *** ****

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