Regulatory Specialist, RRDM-Level 1

Site Name: India - Karnataka - Bangalore R&D
Posted Date: Jan 16 2020
The information managed is the formal record of GSK regulatory activity (documents and data) and is critical to patient safety, regulatory compliance and effective business operations. The post holder is accountable for the quality and accuracy of their own work and for the support of the large number of other users across GSK.

Responsibilities of this role are:

  • Accurate completion of routine data maintenance tasks to agreed schedule
  • Ensure own work is compliant with data standards and defined procedures
  • Ensure defined quality control procedures are followed
  • Capable of performing routine data extraction from RIMS to support KPI generation
  • Maintain knowledge of GSK standards and procedures associated with RIMS and contribute to the definition of new and revised procedures to improve quality and effectiveness
  • Indexing, abstracting and quality assurance of US/UK submissions and associated correspondence into established regulatory document management system(s).
  • Supporting Legal and Business Development project work for document discovery, in-licensing, and out-licensing initiatives.
  • Support customer requests, as needed, by conducting specific searches for proprietary regulatory information using on-line databases.
  • Working on Special projects as required in response to internal and external customer requests.
  • Support for IT related activities
GQA Activities
  • Accurate completion of routine data maintenance tasks to agreed schedule
  • Ensure own work is compliant with data standards and defined procedures
  • Ensure defined quality control procedures are followed
  • Ensure CQA and PVQA data is entered accurately into the audit management system and within the required timelines working on Special projects as required in response to internal and external customer requests.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor's degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment


Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Master's degree
  • Excellent verbal and written communications skills
  • Ability to work carefully under time constraints and prioritize accordingly
  • Adaptable to fast-paced environments with changing circumstances, direction, and strategy
  • Exposure to work within a regulated environment, ideally in drug development

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.


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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