When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Sr. Associate, Regulatory Strategy (Infectious Diseases and Biological Products)

Work location and arrangement: Mexico City - Hybrid

We are seeking a Sr. Associate, Regulatory Strategy with strong experience in regulatory affairs, dossier management, registration applications, and interactions with LATAM Health Authorities.
In this role, you will provide comprehensive regulatory support to the Director, Regulatory Affairs & Quality Assurance, with a focus on COFEPRIS interactions and product lifecycle management.

About the Role




This position offers the opportunity to drive regulatory strategy and execution for product programs in the LATAM region. You will work independently on assigned deliverables while collaborating closely with integral and regional
partners to ensure timely, compliant submissions and approvals.

Key Responsibilities
Regulatory Strategy & Planning
• Support the Director, Regulatory Affairs & Quality Assurance in the execution of regulatory strategies and priorities for product lifecycle

• Perform initial regulatory impact assessments for proposed global changes and provide recommendations on submission requirements, sequencing, dependencies, documentation needs, and anticipated timelines

• Identify and assess regulatory risks, issues, dependencies, and potential delays for assigned activities, and escalate them to the Director with proposed mitigation actions

• Monitor regulatory requirements, COFEPRIS cr

📌 Sr. Associate, Regulatory Strategy (Ciudad de México)
🏢 Parexel
📍 Ciudad de México