HomeRegulatory AffairsRegulatory Specialist, RRDM | Fresher/Exp | Glaxo SmithKline | Bengaluru

Regulatory Specialist, RRDM | Fresher/Exp | Glaxo SmithKline | Bengaluru

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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: Consultant -Regulatory Specialist, RRDM-Level

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 an experienced individual and if you have these skills, we would like to speak to you.

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

  • 2-4 years’ experience in delivering business operational support (in the pharmaceutical industry, life sciences research, or regulatory). Have worked on regulatory submission, have a fair knowledge of the CAPA and audit reports
  • Demonstrated ability to proactively manage workload, timelines, and identify priorities.  Build relationships with relevant internal functions.
  • Proven ability to work on multiple projects simultaneously.
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner
  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.
  • Has worked successfully with a complex computer system
  • Interacts with customers to ensure compliance with regulatory records and data management requirements

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