BENGALURU · FULLTIME
Senior Regulatory Analyst
Coralai
Bengaluru · onsite · Posted 1d ago
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Section · 01
About this role
We are looking for a Regulatory Analyst to work closely with onshore and offshore Lead Business Analysts to understand functional requirements and support regulatory data cleansing, migration, and integration activities. The ideal candidate should have experience in Regulatory Affairs, Regulatory Publishing, CMC Authoring, eCTD, NeeS and paper publishing, regulatory labelling, and quality control processes. The role involves preparing mapping documents, collaborating with technical teams, and ensuring the accuracy and correctness of implementation.
#LI-SP40
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.
Must-Have Skills:
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.
Good-to-Have Skills:
Additional relevant skills to be confirmed.
CGI is an equal opportunity employer. In addition, CGI is committed to providing accommodation for people with disabilities in accordance with applicable 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.
Life at CGI:
It is rooted in ownership, teamwork, respect and belonging. Here, youll reach your full potential because
Come join our team, one of the largest IT and business consulting services firms in the world.
- Business Analysis
- Communication
- MS Office365
- Regulatory affairs
- Analytical Thinking
That same commitment to fairness extends to how we use technology. To support our recruitment team, AI tools may be used to help assess applications though they never replace human judgement. All hiring decisions remain entirely in the hands of our recruitment professionals.
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Section · 02
Skills
Section · Company