GSK Hiring Regulatory Specialist, Country Labelling

GSK Hiring Regulatory Specialist, Country Labelling
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  • Full Time
  • Anywhere

GSK Hiring Regulatory Specialist, Country Labelling

About GSK

GlaxoSmithKline (GSK) is a leading global biopharma company dedicated to improving healthcare through innovative medicines and vaccines. With a strong focus on science, technology, and data, GSK is committed to transforming patient care. Currently, GSK is looking for a Regulatory Specialist III, Country Labelling to join their team in Bangalore, India.

Job Details

Position: Regulatory Specialist III, Country Labelling

  • Company: GSK (GlaxoSmithKline)
  • Location: Bangalore, Karnataka, India
  • Job Type: Full-time
  • Experience Required: 2-6 years
  • Education Qualification: Bachelor’s degree in Science or Life Sciences
  • Application Deadline: March 14, 2025
  • Job Requisition ID: 417056

Key Responsibilities

Regulatory & Compliance

  • Author and compile Regional/Country Product Information (PI) based on regulatory authority requirements and GSK standards.
  • Prepare market-specific supporting documentation for labelling submissions.
  • Ensure compliance with local and global regulatory guidelines.

Documentation & Quality Control

  • Perform quality checks on labelling documents.
  • Efficiently manage regulatory documentation in GSK’s internal systems.
  • Provide expert advice on regulatory labelling requirements.

Communication & Coordination

  • Collaborate with global and local GSK teams, including Regulatory Affairs (GRA), Medical, and Safety teams.
  • May communicate directly with regulatory authorities and third parties.
  • Support ongoing projects and contribute to process improvements.

Additional Responsibilities

  • Assist in implementing new labelling processes.
  • Stay updated with evolving regulatory requirements.
  • Some roles may require translation of labelling documents.
  • Become a Subject Matter Expert in country-specific labelling processes.

Required Skills & Qualifications

  • Bachelor’s degree in Science or Life Sciences.
  • 2-6 years of experience in Regulatory Affairs, specifically in Country Labelling.
  • Strong knowledge of regulatory document management.
  • Experience working with labelling submissions and regulatory systems.
  • Excellent communication skills and ability to work cross-functionally.
  • Familiarity with EU, US, and global labelling regulations is a plus.
  • Experience with XML labelling is advantageous.

Preferred Skills

  • Experience in managing global and local labelling submissions.
  • Regulatory document quality assurance and consistency checking.
  • Hands-on experience with labelling management systems.

Application Process

Interested candidates can apply online through GSK’s official career portal.

Apply Now

Company Overview & Job Summary Table

Company Current Vacancies Required Education Experience Required
GSK (GlaxoSmithKline) Regulatory Specialist III, Country Labelling Bachelor’s degree in Science or Life Sciences 2-6 years

Beware of Recruitment Scams

GSK does not charge any fees for job applications. If you receive emails requesting payments, please report them to askus@gsk.com.

To apply for this job please visit gsk.wd5.myworkdayjobs.com.

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