Regulatory Analyst

Job description

Position Description:

Founded in 1976, CGI is among the largest independent IT and business consulting services firms in the world. With 94,000 consultants and professionals across the globe, CGI delivers an end-to-end portfolio of capabilities, from strategic IT and business consulting to systems integration, managed IT and business process services and intellectual property solutions. CGI works with clients through a local relationship model complemented by a global delivery network that helps clients digitally transform their organizations and accelerate results. CGI Fiscal 2024 reported revenue is CA$14.68 billion and CGI shares are listed on the TSX (GIB.A) and the NYSE (GIB). Learn more at cgi.com.

Job Title: Junior Regulatory Analyst
Position: Lead Analyst
Experience: 3-5 Years
Category: Software Development/ Engineering
Shift: General
Main location: Bangalore/HYD/Chennai
Position ID: J0326-2979
Employment Type: Full Time
Education Qualification: Bachelor's degree in Pharma or related field or higher with minimum 3 years of relevant experience.
Position Description:
Junior Regulatory Affairs Consultant with 3–5 years of experience to support regulatory operations, publishing, and RIM-related activities, working closely with business and technical teams.

Your future duties and responsibilities:

• Support requirement gathering with business analysts
• Assist in preparing mapping documents for data migration and cleansing
• Work with technical teams for implementation support
• Support regulatory publishing (eCTD, NeeS, paper formats)
• Assist in CMC authoring, labeling, and QC activities
• Perform QC checks and help resolve issues
• Support RIM system activities and data migration
• Ensure timely and compliant regulatory submissions

Required qualifications to be successful in this role:

Must-Have Skills
• Experience in Regulatory Affairs processes
• Hands-on exposure to regulatory publishing and submissions
• Knowledge of eCTD, NeeS, and paper formats
• Experience in QC checks and basic data migration concepts
• Understanding of regulatory labeling
• Familiarity with tools like SmartDesk, ISI Toolbox, ACUTA RIM
• Exposure to publishing tools like Veeva Vault, Lorenz, or Insight Suite
• Good analytical and communication skills

Good-to-Have Skills
• Exposure to global regulatory environments
• Basic knowledge of RIM systems
• Familiarity with compliance across regions
• Strong documentation skills

CGI is an equal opportunity employer. In addition, CGI is committed to providing accommodation for people with disabilities in accordance with provincial legislation. Please let us know if you require reasonable accommodation due to a disability during any aspect of the recruitment process and we will work with you to address your needs.

Skills:

·  Analytical Thinking
·  Business Analysis

What you can expect from us:

Together, as owners, let’s turn meaningful insights into action.

Life at CGI is rooted in ownership, teamwork, respect and belonging. Here, you’ll reach your full potential because…

You are invited to be an owner from day 1 as we work together to bring our Dream to life. That’s why we call ourselves CGI Partners rather than employees. We benefit from our collective success and actively shape our company’s strategy and direction.

Your work creates value. You’ll develop innovative solutions and build relationships with teammates and clients while accessing global capabilities to scale your ideas, embrace new opportunities, and benefit from expansive industry and technology expertise.

You’ll shape your career by joining a company built to grow and last. You’ll be supported by leaders who care about your health and well-being and provide you with opportunities to deepen your skills and broaden your horizons.

Come join our team—one of the largest IT and business consulting services firms in the world.