Senior Regulatory Analyst

Position Description:

Founded in 1976 CGI is among the largest independent IT and business consulting services firms in the world. With 94000 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 .
Job Title: Senior Regulatory Analyst
Position: Lead Analyst
Experience: 8 - 10 Years
Category: Software Development/ Engineering
Shift: General
Main location: Bangalore/HYD/Chennai
Position ID: J1025-1647
Employment Type: Full Time
Education Qualification: Bachelors degree in Computer Science or related field or higher with minimum 5 years of relevant experience.

Position Description:
We are seeking a highly skilled and detail-oriented Regulatory Affairs Consultant to join our this role you will collaborate with onshore and offshore Lead Business Analysts to understand functional requirements and translate them into comprehensive mapping documents for data cleansing migration and system integration initiatives. You will work closely with technical teams to ensure accurate and compliant implementation of regulatory solutions. Your expertise in Regulatory Affairs publishing processes and RIM systems will be essential in delivering high-quality and compliant outcomes.

Your future duties and responsibilities:

Collaborate with onshore and offshore Lead Business Analysts to gather and analyze functional requirements.
Prepare detailed mapping documents to support data cleansing migration and integration activities.
Work closely with technical teams to ensure accurate implementation aligned with regulatory and business requirements.
Support Regulatory Affairs processes including publishing CMC authoring labeling and quality control activities.
Manage and support regulatory submissions including eCTD NeeS and paper publishing formats.
Perform QC checks and fixes to ensure compliance and data accuracy.
Support migration activities and system transitions within Regulatory Information Management (RIM) environments.
Utilize regulatory QC and publishing tools to ensure timely and compliant submissions.
Identify process improvements and contribute to best practices in regulatory operations and system implementations.

Required qualifications to be successful in this role:

Must-Have Skills:
Strong experience in Regulatory Affairs processes and operations.
Hands-on experience with Regulatory Publishing CMC Authoring eCTD NeeS and paper publishing.
Experience in QC Fixes data migration and system integration activities.
Experience with Regulatory Labelling processes.
Proficiency in QC Tools such as SmartDesk ISI Toolbox and ACUTA RIM.
Experience with Publisher Tools such as Veeva Vault Lorenz and Insight Suite.
Strong analytical skills with experience in preparing mapping documents for data migration and integration.
Ability to collaborate effectively with cross-functional and geographically distributed teams.

Good-to-Have Skills:

Experience working in global regulatory environments.
Exposure to Regulatory Information Management (RIM) system implementations or upgrades.
Familiarity with compliance standards and regulatory submission requirements across multiple regions.
Strong documentation and communication skills.

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CGI is an equal opportunity 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 lets turn meaningful insights into action.

Life at CGI is rooted in ownership teamwork respect and belonging. Here youll 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. Thats why we call ourselves CGI Partners rather than employees. We benefit from our collective success and actively shape our companys strategy and direction.

Your work creates value. Youll 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.

Youll shape your career by joining a company built to grow and last. Youll 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 teamone of the largest IT and business consulting services firms in the world.