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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Director, Global Regulatory Affairs at Pfizer Inc.
Montreal, Quebec Canada
RAC holder since 2019
As a global regulatory strategist, I work on designing, progressing, and monitoring the execution of the global regulatory strategy for anti-infective assets in emerging markets. I work with a complex matrix of cross-functional colleagues at global, regional, and market levels. The assets I manage are in different stages of development—from early clinical phases (Phase 1/2) through registration phases.
I led a rapid response team of subject matter experts who were gathered to address challenging queries from the health authority in a major market in Asia. Together, we turned the tide from potential rejection of the product to final approval.
Yes! Being well rounded in the regulatory frameworks of different emerging markets—especially key markets like China—is key to top performance as a strategist. The knowledge and skills I gained in preparing for the RAC exam was a major contributor to a successful strategy in China for one of the assets under my responsibility. The knowledge I gained helped me guide a team of regulatory colleagues to achieve breakthrough goals in China’s complex review process.
Regulatory is an interesting career with the ever-evolving environment worldwide. Set your goals. A regulatory job is not just filling and submitting applications. It is about thinking critically regarding the objectives and timelines, analyzing the situation, then crafting a strategy that ensures the success of the submission. It requires strong soft skills as well as technical knowledge.