🍁 SearchCanadaJobs.com

Regulatory Affairs Specialist (Replacement of maternity leave, 2Y Contract)

Company

622 GlaxoSmithKline Korea Limited

Location

Seoul, Seoul

Type

Full time

JOB PURPOSE

Lifecycle Management of Existing Products

  • Plan, prepare, and submit regulatory variations for marketed products, including CMC changes, labeling updates, and maintenance of product licenses, ensuring ongoing regulatory compliance.

  • Support for Regional and Global Regulatory Projects

  • Manage and execute assigned regulatory projects and activities requested by regional and global stakeholders, ensuring timely delivery and alignment with business objectives.

  • Regulatory Issue Management

  • Identify, assess, and address regulatory issues related to assigned products, providing regulatory guidance and coordinating with internal and external stakeholders as needed.

  • RESPONSIBILITIES

  • Manage regulatory lifecycle activities for marketed products including shelf-life extensions, CMC variations, manufacturing site transfers, GDS updates, renewals, and other post-approval c...

  • 🍁 Ready to Apply?

    Take the next step in your Canadian career

    Apply Now