Regulatory Affairs Specialist
hace 4 semanas
Join a global team of innovators at Novartis, where we're pushing the boundaries of medical science and digital technology to bring life-changing medicines to millions of people. As a Regulatory Affairs Specialist, you'll play a critical role in ensuring the quality and compliance of our products.
**Key Responsibilities:**
Coordinate and prepare high-quality submissions of regulatory dossiers for assigned products
Ensure timely license renewal submissions and approvals
Assist in coordinating face-to-face meetings with cross-functional areas for project discussions
Communicate questions referred by Health Authorities in a timely and smooth manner
Update and communicate registration status to line managers
Order and track registration documents, dossiers, and certificates
Provide regulatory support to other functions, including marketing, medical, access, and supply chain
Establish good communication and relationships with key stakeholders
**What You'll Bring:**
Complete degree in life science or related field
Minimum 1 year of experience in Regulatory Affairs in the pharmaceutical segment
English Intermediate
Spanish Fluent
**Why Novartis?**
We're committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
We believe new insights, perspectives, and groundbreaking solutions can be found at the intersection of medical science and digital innovation.
We're proud of our impact – 766 million lives were touched by Novartis medicines in 2021.
**Division:** Global Drug Development
**Business Unit:** REG AFFAIRS GDD
**Country:** Mexico
**Work Location:** Ciudad de México
**Company/Legal Entity:** NOV CORPORATIVO MEX
**Functional Area:** Research & Development
**Job Type:** Full Time
**Employment Type:** Regular
**Shift Work:** No
**Early Talent:** Yes
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