Regulatory Specialist, Reg Systems
- Bengaluru, India
Site Name: India - Karnataka - Bengaluru
Posted Date: Jan 5 2021
Are you energized by a highly impactful regulatory affairs role that allows you to shape and accelerate regulatory effectiveness across the organization? If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore.
As Regulatory Operations Manager, you will be responsible for leading or supporting strategic and operational Regulatory projects, which support business strategy and platform delivery.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following...
- Provide operational support and strategic direction to GRPD for Regulatory Systems
- Deliver and lead the ownership and business support for a varied portfolio of off the shelf and bespoke regulatory systems that are used globally for the delivery and maintenance of regulatory activities.
- Manage business, project and support challenges globally
- Lead the interface with IT, Business System Owners to coordinate solutions delivery and support.
- Develop project proposals and business cases to address the tactical and strategic needs of the business.
- Lead the business engagement in projects in collaboration with IT and Business Project Teams.
Bachelors degree (IT / Science / Technical)
Significant experience delivering business operational support and strategic direction for critical regulatory systems in a global environment (Regulatory Information Management and Reporting, Electronic Publishing and Validation Systems, Electronic Data Exchange and/or Labeling Management Systems).
Lead Business Change Teams delivering IT solutions for the business.
Expert in experience working within a regulated project delivery environment including standard GSK change control and validation procedures.
Drive support assistance and support on both sides of the Business-IT interface.
Significant experience managing system ownership including change control and system lifecycle management within a regulated environment, ideally in drug / vaccines development.
Experience developing solution based on business analysis needs and external drivers.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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