Infosys
Website:
infosys.com
Job details:
We are seeking a seasoned Regulatory Management Subject Matter Expert to join our consulting team and lead global regulatory operations, submissions, and compliance transformation initiatives.
🔹 Role Responsibilities:
- Lead Regulatory Management across R&D—eCTD submission tracking and reporting, marketing authorization submissions, submission document creation, and product registrations
- Manage regulatory agency interactions and support inspection‑ready regulatory operations
- Oversee CMC and regulatory compliance, ensuring alignment with global health authority requirements
- Drive digital, AI, and automation initiatives from information technology standpoint—submission tracking automation, document intelligence, workflow optimization, and compliance analytics. Should be able to provide technology consulting advise to pharmaceutical customers
- Partner with clients on program/project management and regulatory transformation engagements.
🔹 Key Skills & Tools:
- Deep expertise in Regulatory Management (eCTD, MA submissions, product registrations, CMC)
- Tools: Planisware, RIMS, eCTD tools, PROTON, Veeva, DMS (plus safety system integrations where applicable)
- Strong project/program management, research, and analysis capabilities
- Ability to translate regulatory complexity into scalable, technology‑enabled operating models
🔹 Why Join Us:
Be part of a consulting team shaping the future of digitally enabled, inspection‑ready Regulatory Operations, leveraging AI, automation, and data‑driven insights for global life sciences clients.
Click on Apply to know more.