Product Manager - RIMS

Key Responsibilities:

• Gathering customer requirements and prioritizing product backlog for digital initiatives in Regulatory Function.
• Collaborate with leaders across Regulatory Affairs function to ideate on new use cases, or/and enhance functionalities in existing applications.
• Manage agency (FDA, EMA, etc.) expectations for regulatory applications (Regulatory Information Management System) by analysing latest reports/ guidelines.
• Drive solution adoption and scale up as per defined product roadmap for ensuring planned value realization.
• Contribute in building Digital Quotient across the organizations through Trainings & Workshops on new & emerging digital technologies and their potential use cases in the domain of Regulatory Affairs.
• Work effectively with cross functional team members including but not limited to Digital COE, Analytics COE, SAP COE, CSV, DQA and Legal.
• Drive digital and analytics projects from concept till launch and ensure delivery as per budgeted cost, timelines and quality.
• Adherence to Digital Product/ Solution Development best practices and processes such as Design Thinking, & Agile Scrum for ensuring optimum program outcomes.
• Adherence to Regulatory best practices for ensuring GxP compliance for digital applications.

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Cipla manufactures metered-dose inhaler devices, spacers and related devices; and conducts R&D to develop new medicines and drug delivery systems. The company has operations in India, US, Canada, South Africa and major regulated and emerging markets among others. Cipla is headquartered in Mumbai, Maharashtra, India.