04 oct
|
Praxy
|
Ciudad de México
04 oct
Praxy
Ciudad de México
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary:
The Regulatory Tactical Manager is the operational engine of the Mexico regulatory function: it converts approved strategy into executable tactical plans, operates the day-to-day project governance mechanics (trackers, cadences, escalation logs) that support the Country Head's governance model, and provides hands-on technical execution — including direct dossier compilation support and technical/tactical guidance to third parties (distributors, licensing partners) responsible for local submissions.
The role is also the function's operational owner for AI-enabled tools and digital automation, embedding practical use cases into daily regulatory work.
Duties/Responsibilities
- Own and operate the day-to-day governance mechanics — trackers, milestone dashboards, escalation logs — that put the Country Head's single-threaded governance model into practice for the assigned portfolio.
- Track dependencies, risks, and milestones across the portfolio, flagging deviations early enough for tactical correction before they require executive escalation.
2) Dossier Technical Execution & Third-Party Tactical Guidance
- Provide hands‑on technical compilation support for dossiers (new registrations, renewals, variations, CMC changes), assembling and quality‑checking content against COFEPRIS/eCTD requirements ahead of Senior Manager review.
- Act as the direct technical and tactical point of contact for third parties (distrib
📌 Regulatory Affairs Tactical (Ciudad de México)
🏢 Praxy
📍 Ciudad de México