Regulatory Analyst

Position Description:

We are looking for a Regulatory Affairs Business Analyst with 45 years of experience to support regulatory operations and publishing processes within the life sciences domain. The candidate will collaborate with Lead Business Analysts (onshore and offshore) to understand functional requirements and assist in preparing mapping documents for data cleansing migration and integration activities.

The role involves working closely with technical teams to ensure proper implementation of regulatory solutions and supporting regulatory publishing submission preparation and quality control activities.
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Your future duties and responsibilities:

Work with Lead Business Analysts and stakeholders to understand and document functional requirements.

Prepare mapping documents for regulatory data cleansing migration and integration.

Coordinate with technical teams to support accurate implementation of regulatory systems.

Support regulatory publishing processes including document preparation validation and submissions.

Perform QC checks and fixes for regulatory submission documents.

Assist with migration and system transition activities for regulatory platforms.

Support regulatory labeling activities where required.

Maintain documentation for requirements workflows and regulatory processes.

Required qualifications to be successful in this role:

Must-Have Skills

45 years of experience in Regulatory Affairs or Regulatory Publishing.

Experience with eCTD NeeS and paper publishing processes.

Exposure to CMC Authoring.

Experience in QC fixes and regulatory submission validation.

Understanding of data migration and regulatory data management.

Ability to prepare mapping documents for data cleansing migration and integration.

Experience working with cross-functional teams (onshore/offshore).

Good-to-Have Skills

Experience with QC Tools: SmartDesk ISI Toolbox ACUTA RIM.

Exposure to Publishing Tools: Veeva Vault Lorenz Insight Suite.

Understanding of Regulatory Information Management (RIM) systems.

Knowledge of regulatory labeling processes.

Experience in pharmaceutical or life sciences regulatory environments.

Skills:

• Business Analysis
• Analytical Thinking

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.