ICON Work from Home Jobs; Hiring Associate – Apply Now

Remote Regulatory Operations Associate Job Openings 2025!!!

ICON announced job vacancy for the post of Regulatory Operations Associate. The place of posting will be at Remote (WFH). Candidates who have completed Graduate / Engineering / Post Graduate with Fresher / Experience are eligible to apply. More details about qualifications, job description and roles & responsibilities are as follows

Name of the Company	ICON
Required Qualifications	Graduate
Category	Service & Corporate Support
Work Type	Remote

ICON plc is a world-leading healthcare intelligence and clinical research organization. They’re proud to foster an inclusive environment driving innovation and excellence, and they welcome you to join them on their mission to shape the future of clinical development. At ICON, it’s their people that set them apart. Their diverse teams enable them to become a better partner to their customers and help them to fulfil their mission to advance and improve patients’ lives.

Their ‘Own It’ culture is driven by four key values that bring them together as individuals and set them apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. They want to be the Clinical Research Organisation that delivers excellence to their clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That’s their vision. They’re driven by it. And they need talented people who share it. If you’re as driven as they are, join them. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Θ Positions: Regulatory Operations Associate

Θ Job Location: Remote (WFH) – Bengaluru / Chennai / Trivandrum

Θ Salary: As Per Company Norms

Θ Job Type: Full Time

Θ Requisition ID: JR131320

Roles and Responsibilities:

• Provide support for submissions and other documents by performing necessary tasks including photocopying, scanning and printing, assembly, dispatch and coordinating resources for submissions
• Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities.
• Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines
• Assemble electronic and paper Regulatory Submissions and packages for Health Canada, US Food and Drug Administration, the European Medicines Agency and other international regulatory authorities using specialty EDMS/publishing software
• Perform quality review of Regulatory Operations team members work to ensure accuracy
• Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when required

Required Skills & Qualifications:

• B.Sc. or related degree in Health Sciences or Information Technology / Computer Sciences or equivalent relevant experience and training. RAC certification an asset
• 2 years pharmaceutical regulatory industry / regulatory operations experience
• Experience working with current eCTD standards desirable
• Understanding of applicable regulations and guidelines documents

 

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