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Regulatory Affairs Manager (12 months fixed-term)

Company

AstraZeneca

Location

Warsaw, Poland

Type

Full time

Description

:

The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Accountabilities/Responsibilities:

  • Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
  • Provide regulatory input on procedural and documentation requirements as defined by Health Auth...
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