Regulatory Specialist MSR coordination Senior

Site Name: India - Karnataka - Bangalore R&D
Posted Date: Sep 30 2019
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...

  • Fulfil standard, ad hoc, or complex data reporting request and design outputs.
  • Assist Regulatory Business Operations (RBO) staff in delivery of projects.
  • Assist RBO staff in process documentation, monitoring, and reporting.
  • Maintain Team sites.
  • Adhere to records retention.
  • Complete appropriate training.
  • Assist Regulatory Business Operations staff to optimize project plan robustness (scope, deliverables, resources, timing).
  • Provide project support to meet assigned business deliverables.
  • Edit existing process documentation and lead monitoring and reporting.
  • Provide analysis and interpretation of information in response to requests from requestors and pursue greater data quality through identification of gaps and delivery of efficient solutions.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree.
  • 3 years of pharmaceutical industry experience in a regulatory environment.
  • Experience with License Maintenance as well as overall R&D processes.
  • Direct experience with project planning & execution.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Master's degree or MBA
  • Experience working in a matrixed environment
  • Demonstrated ability to engage and influence senior stakeholders.

Why GSK?

Our values and expectationsare 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:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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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