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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.

Position: Regulatory Specialist, RRDM-Level 1

Location: Bengaluru, Karnataka

Job Description:

Responsibilities of this role are:

  • Accurate completion of routine data maintenance tasks to the agreed schedule
  • Ensure your 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 the established regulatory document management system(s).
  • Supporting Legal and Business Development project works 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 the agreed schedule
  • Ensure your 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.

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 working within a regulated environment, ideally in drug development

Experience: 0-2 Years

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