Company Profile:
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: Senior Regulatory Analyst
Position: Senior Regulatory Analyst
Experience: 5+ Years
Category: Regulatory Affairs / Life Sciences
Main location: Hyd/Ban/Che
Position ID: J0826-1201
Employment Type: Full Time
Position Description:
We are looking for an experienced Senior Regulatory Analyst to work with Lead Business Analysts across onshore and offshore teams to understand functional requirements and support regulatory-related data and document activities.
The candidate will be responsible for preparing mapping documents for data cleansing, migration, and integration and will work closely with the technical team to ensure that the implementation is correct.
The ideal candidate should have experience in Regulatory Affairs, Regulatory Publishing, CMC Authoring, eCTD, NeeS/Paper Publishing, QC Fixes, Regulatory Labelling, and relevant regulatory QC and publishing tools.
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Your future duties and responsibilities
- Work with Lead Business Analysts across onshore and offshore teams to understand functional requirements.
- Prepare mapping documents for data cleansing, migration, and integration activities.
- Collaborate with the technical team to ensure that the implementation is correct.
- Support regulatory publishing activities and related processes.
- Work on CMC Authoring and regulatory documentation.
- Support eCTD and NeeS/Paper Publishing activities.
- Perform and support QC fixes.
- Work on Regulatory Labelling activities.
- Use relevant QC and regulatory publishing tools as required.
- Collaborate with business and technical stakeholders to support successful implementation.
Required qualifications to be successful in this role
Must-Have Skills:
- Experience in Regulatory Affairs.
- Experience in Regulatory Publishing.
- Experience in CMC Authoring.
- Experience with eCTD.
- Experience with NeeS / Paper Publishing.
- Experience with QC Fixes.
- Experience in Regulatory Labelling.
- Experience preparing mapping documents for data cleansing, migration, and integration.
- Experience working with Lead Business Analysts and technical teams.
- Experience working with regulatory QC and publishing tools.
QC Tools:
- SmartDesk
- ISI Toolbox
- ACUTA RIM
Publisher Tools:
- Veeva Vault
- Lorenz
- Insight Suite
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.
Life at CGI:
It 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 us, one of the largest IT and business consulting services firms in the world.
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.
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.
Come join our team—one of the largest IT and business consulting services firms in the world.
