Regulatory Affairs Manager Role at ICON PLC

ICON PLC is a global Clinical Research Organization (CRO) that specializes in providing innovative solutions and services to the pharmaceutical, biotechnology, and medical device industries. With over 30 years of experience, ICON has established itself as a trusted partner in drug development, helping clients bring life-saving therapies to market efficiently and effectively.

Founded in 1990 and headquartered in Dublin, Ireland, ICON operates in more than 45 countries worldwide, with a team of over 15,000 dedicated professionals. Our mission is to accelerate the development of new drugs and medical treatments through our expertise in clinical research and regulatory affairs.

ICON PLC Vacancies List

• Position Title: Regulatory Affairs Manager
• Company Name: ICON PLC
• Locations: India (Bangalore, Trivandrum, Chennai)
• Time Type: Full-Time
• Job Requisition ID: JR115600

Job Description

Role: Regulatory Affairs Manager

Industry Type: Healthcare/Clinical Research

Department: Regulatory Affairs

Employment Type: Full-Time

Role Category: Regulatory Affairs

About the Department & Responsibilities

As a Regulatory Affairs Manager at ICON, you will be part of our Global Regulatory Affairs team, which provides consultancy for all ICON projects globally. You will manage regulatory affairs activities for clinical trials and projects undertaken by ICON, ensuring compliance with regulatory standards and client requirements. Your responsibilities will include:

• Leading process improvement initiatives to streamline regulatory processes and add value to our business.
• Applying scientific principles to maximize compliance in all regulatory activities.
• Preparing and supporting proposals and bids for regulatory projects.
• Managing all aspects of allocated projects, including tracking, risk identification, scope change, and financial management.
• Participating in regulatory and clinical trials project teams as required.
• Contributing to the development of regulatory strategies to enhance ICON’s competitive advantage.

Qualifications and Requirements

• Significant experience in regulatory affairs, preferably in the pharmaceutical/CRO industry.
• Demonstrable experience in document preparation, clinical trials, and regulatory agency interaction.
• Strong organizational skills and attention to detail.
• Excellent written and verbal communication skills in English.
• Proficiency in Microsoft Office suite.
• Bachelor’s degree in a relevant field (e.g., Life Sciences); Master’s degree preferred.

How to Apply

If you are interested in joining ICON PLC as a Regulatory Affairs Manager, please apply online using the following link: ICON PLC Careers Portal