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Regulatory Operations & Publishing Jobs at ICON plc – Remote/Home-Based

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ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing drug development and improving patient outcomes. With a strong focus on innovation, ICON provides outsourced services to pharmaceutical, biotech, and medical device companies. The company fosters an inclusive, high-performance culture with core values of accountability, collaboration, and integrity.

Job Openings at ICON plc

1. Regulatory Operations Associate (Home-Based – Bangalore/Chennai/Trivandrum)

Job ID: JR131320

Key Responsibilities:

  • Support regulatory submissions by preparing, assembling, and dispatching documents.
  • Publish submissions in electronic (eCTD) and paper formats for FDA, EMA, Health Canada, and other agencies.
  • Ensure compliance with regulatory guidelines and internal processes.
  • Perform quality reviews and manage submission workflows.

Eligibility:

  • Education: B.Sc. in Health Sciences, IT, or related field (RAC certification a plus).
  • Experience: 2+ years in regulatory operations/pharmaceutical industry.
  • Skills: Knowledge of eCTD standards, regulatory guidelines, and document management.

Benefits:

  • Competitive salary & performance bonuses.
  • Health insurance, retirement plans, life assurance.
  • Flexible work options & global career growth.


2. Senior Regulatory Publishing Specialist (Home-Based – China/India)

Job ID: JR131318

Key Responsibilities:

  • Lead eCTD/NeeS submissions for global regulatory agencies.
  • Act as a Subject Matter Expert (SME) for submission requirements.
  • Ensure compliance with publishing standards and quality control.
  • Collaborate with cross-functional teams for complex submissions.

Eligibility:

  • Education: Bachelor’s degree in a relevant field.
  • Experience: 3+ years in regulatory publishing/eCTD submissions.
  • Skills: Proficiency in publishing tools (e.g., DocuBridge, Lorenz), strong communication.

Benefits:

  • Career development & training programs.
  • Health & wellness benefits, retirement plans.
  • Remote work flexibility.


How to Apply

🔗 Apply Now for Regulatory Operations Associate

🔗 Apply Now for Senior Regulatory Publishing Specialist

Regulatory Operations & Publishing Jobs at ICON plc – Remote/Home-Based
Regulatory Operations & Publishing Jobs at ICON plc – Remote/Home-Based