Icon Plc Hiring Regulatory Affairs Specialists

Icon Plc Hiring Regulatory Affairs Specialists
  • Full Time
  • Anywhere

Icon Plc Hiring Regulatory Affairs Specialists

About the Company

Icon Plc is a leading Clinical Research Organization (CRO) committed to advancing and improving patients’ lives. Our diverse teams foster a culture of accountability, collaboration, partnership, and integrity, making us a preferred partner in drug development. At Icon, we believe in an “Own It” culture that sets us apart and drives us to deliver excellence at every touchpoint in clinical research.

Company Vacancies List

  • Position Title: Regulatory Affairs Specialist
  • Locations: Bangalore, Chennai, Trivandrum, Bengaluru
  • Job Reference: JR111991
  • Department: Drug/Device Regulatory Affairs Hybrid: Office/Remote

Job Description

As a Regulatory Affairs Specialist at Icon Plc, you will:

  • Provide advice and support to project teams on regulatory operations aspects.
  • Maintain positive and productive relationships with internal and external contacts.
  • Lead project teams, advising on regulatory standards issues and strategies.
  • Develop, write, and implement standards and procedures related to regulatory operations.
  • Identify client issues, develop alternative strategies, and actively participate in business-related projects.
  • Experience in eCTD, NeeS, Paper Submissions, EU, US, and Canada HA submissions.
  • Good knowledge of CTD sections.

About the Department & Responsibilities

The Regulatory Affairs department plays a crucial role in ensuring compliance with regulatory standards. As a Regulatory Affairs Specialist, you will lead project teams, advise on regulatory strategies, and contribute to the development and implementation of standards and procedures related to regulatory operations.

How to Apply

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