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Luis Angel Monroy
Regulatory Strategy Associate Director @Bristol Myers Squibb
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WORK HISTORY
Regulatory Strategy Associate Director @Bristol Myers Squibb
MX
I lead end-to-end regulatory strategy in Mexico, enabling timely and sustainable access to transformative therapies through innovative, locally adapted execution that supports long-term product value.Positioned at the intersection of policy, science, and business, I translate complex regulatory and legal frameworks into actionable pathways that drive impact for both patients and the organization.I manage the full regulatory lifecycle—from New Molecule Committees and Marketing Authorizations to regulatory lifecycle planning, and market strategies—ensuring alignment with COFEPRIS and other key stakeholders.I’m passionate about empowering cross-functional teams, fostering innovation in how we work, and helping others build the future they want with agility and purpose.I love to empower the team to explore new ways of work and I help them to build the future they want.Outcomes first 4 months:1 New Marketing Authorization7 New Molecule Committee approvals.A major tax-impact transition project executedLed strategic technical sessions with COFEPRIS to align regulatory priorities and define key product strategies.
ABOUT LUIS ANGEL MONROY
With over 18 years of experience in regulatory affairs within the pharmaceutical…
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