Product Manager - RIMS
1 year ago Engineering Hyderabad 83 views Reference: 31136Job Details
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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Company Description
Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company based in Hyderabad. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited.[2] Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology.
Dr. Reddy's began as a supplier to Indian drug manufacturers, but it soon started exporting to other less-regulated markets that had the advantage of not having to spend time and money on a manufacturing plant that would gain approval from a drug licensing body such as the U.S. Food and Drug Administration (FDA). By the early 1990s, the expanded scale and profitability from these unregulated markets enabled the company to begin focusing on getting approval from drug regulators for their formulations and bulk drug manufacturing plants in more-developed economies. This allowed their movement into regulated markets such as the US and Europe. In 2014, Dr. Reddy Laboratories was listed among 1200 of India's most trusted brands according to the Brand Trust Report 2014, a study conducted by Trust Research Advisory, a brand analytics company.[3]
By 2007, Dr. Reddy's had seven FDA plants producing active pharmaceutical ingredients in India and seven FDA-inspected and ISO 9001 (quality) and ISO 14001 (environmental management) certified plants making patient-ready medications five of them in India and two in the UK.[4]
Dr. Reddy's began as a supplier to Indian drug manufacturers, but it soon started exporting to other less-regulated markets that had the advantage of not having to spend time and money on a manufacturing plant that would gain approval from a drug licensing body such as the U.S. Food and Drug Administration (FDA). By the early 1990s, the expanded scale and profitability from these unregulated markets enabled the company to begin focusing on getting approval from drug regulators for their formulations and bulk drug manufacturing plants in more-developed economies. This allowed their movement into regulated markets such as the US and Europe. In 2014, Dr. Reddy Laboratories was listed among 1200 of India's most trusted brands according to the Brand Trust Report 2014, a study conducted by Trust Research Advisory, a brand analytics company.[3]
By 2007, Dr. Reddy's had seven FDA plants producing active pharmaceutical ingredients in India and seven FDA-inspected and ISO 9001 (quality) and ISO 14001 (environmental management) certified plants making patient-ready medications five of them in India and two in the UK.[4]
