Regulatory Analyst
CGI
Bengaluru, Karnataka, India2+ yrs4h agovia LinkedIn
About the Role
CGI is seeking a Regulatory Analyst to support regulatory data cleansing, migration, and integration activities.
Key Responsibilities
- Work with onshore and offshore Lead Business Analysts to understand functional requirements.
- Prepare mapping documents for data cleansing, migration, and integration.
- Collaborate with technical teams to ensure correct implementation of functional requirements.
- Support regulatory data migration and integration activities.
- Perform regulatory publishing activities, including eCTD, NeeS, and paper publishing.
- Support CMC Authoring and regulatory labelling activities.
- Handle QC fixes and support quality control activities.
- Work with relevant QC and publisher tools to support regulatory processes.
Requirements & Tech Stack
- Experience in Regulatory Affairs.
- Experience in Regulatory Publishing.
- Experience in CMC Authoring.
- Knowledge of eCTD, NeeS, and paper publishing.
- Experience in QC fixes and migration.
- Experience in Regulatory Labelling.
- Familiarity with QC tools such as SmartDesk, ISI Toolbox, and ACUTA RIM.
- Familiarity with publisher tools such as Veeva Vault, Lorenz, and Insight Suite.
- Ability to understand functional requirements and prepare mapping documents for data cleansing, migration, and integration.
- Ability to collaborate with onshore/offshore business analysts and technical teams.