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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