We're Nagarro, we are a Digital Product Engineering company that is scaling in a big way! We build products, services, and experiences that inspire, excite, and delight. We work at scale across all devices and digital mediums, and our people exist everywhere in the world (17500+ experts across 39 countries, to be exact). Our work culture is dynamic and non-hierarchical. We are looking for great new colleagues. That is where you come in!

REQUIREMENT:

- We are hiring experience in Regulatory Affairs, Regulatory Operations, RIM Consulting, or Regulatory Technology within the Life Sciences industry.
- Deep functional expertise including:
- Registrations
- Submissions
- Submission Archive
- Publishing
- Robust understanding of recent Veeva Vault RIM features, capabilities, and industry best practices.
- Proven experience in client consulting, strategic advisory, business transformation, and solution pitching.
- Expertise in global regulatory submission standards and frameworks, including:
- eCTD
- IDMP
- RIM Data Models
- Regional Health Authority Requirements
- Strong knowledge of regulatory lifecycle processes from submission planning through registration management.
- Excellent stakeholder management and executive communication skills.
- Demonstrated ability to develop business cases, value propositions, and transformation roadmaps.
- Strategic thinking and problem-solving mindset.
- Strong presentation and storytelling abilities.
- Ability to influence senior business stakeholders.
- Consulting-oriented approach with focus on business outcomes.




- Leadership skills with the ability to act as a client-facing domain expert.
- Strong collaboration and relationship-building capabilities.
- Experience supporting regulatory transformation programs.
- Exposure to multiple global regulatory markets and health authorities.
- Experience working with pharmaceutical, biotechnology, or medical device organizations.
- Prior experience in advisory, consulting, or pre-sales engagements related to Regulatory Affairs and RIM solutions.

RESPONSIBILITIES:

- Writing and reviewing great quality code
- Understanding functional requirements thoroughly and analysing the clients needs in the context of the project
- Envisioning the overall solution for defined functional and non-functional requirements, and being able to define technologies, patterns and frameworks to realize it
- Determining and implementing design methodologies and tool sets
- Enabling application development by coordinating requirements, schedules, and activities.
- Being able to lead/support UAT and production roll outs
- Creating, understanding and validating WBS and estimated effort for given module/task, and being able to justify it
- Addressing issues promptly, responding positively to setbacks and challenges with a mindset of continuous improvement
- Giving constructive feedback to the team members and setting clear expectations.
- Helping the team in troubleshooting and resolving of complex bugs
- Coming up with solutions to any issue that is raised during code/design review and being able to justify the decision taken
- Carrying out POCs to make sure that suggested design/technologies meet the requirements

📌 Associate Principal Engineer (Regulatory Affairs) (Pune)
🏢 Nagarro
📍 Pune