Monique P. Richards
CEO | Spartan competitor | $100M+ Deliveries in 3 yrs | Patient Advocate | Project Manager | Public Speaker | Shaping Inclusive Research & Patient Access | Turning Strategy into Measurable Patient Outcomes | Ex-Merck
- Role
- Director, Global Regulatory Affairs at Daiichi Sankyo US
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Monique P. Richards
In my most recent role, I’ve delivered $200M+ in value through regulatory, clinical, and…
Experience
Director, Global Regulatory Affairs
Jul 2022 — Present
At Daiichi Sankyo, I direct global regulatory labeling strategy for oncology and rare disease portfolios. I lead a cross-functional team of 25+ experts across North America, Europe, and Asia, ensuring alignment with regulatory expectations and corporate objectives. I spearheaded the implementation of Veeva Vault SCMS, which strengthened data integrity, audit readiness, and global consistency. Under my leadership, my teams have accelerated submissions by 40% and improved labeling quality across high-stakes oncology ADCs and rare disease assets.
Education
Harvard Graduate School of Education
Certificate
Creighton University
Doctor of Pharmacy (Pharm.D.)
Howard University
Bachelor’s Degree
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