Senior Regulatory Specialist
3 tygodni temu
As a Senior Regulatory Specialist - Country Labelling, you will be responsible for effective coordination, communication, and maintenance of regional/country labelling documents and data in regulatory systems.
Key Responsibilities- Author and compile Regional/Country Product Information as per regulatory authority labelling requirements and GSK process and standards.
- Author and compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.
- Provide support to global and local GRA team members through preparation of other labelling documents as required.
- Complete quality and consistency checks of labelling document content.
- Efficiently coordinate and manage labelling documentation and data in regulatory systems.
- Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.
- Effectively communicate with GSK staff to author, compile, and deliver quality labelling documents.
- Support other regulatory functions and participate in other projects and activities as needed.
- Subject Matter Expert in country/regional labelling content and process for markets with complex labelling requirements.
- Relevant experience in the pharmaceutical industry, life sciences research, or regulatory.
- Masters degree in Science or Life Sciences.
- Successfully performed within a regulated or quality-critical environment.
- Understanding of labelling regulations and requirements.
- Experience in updating and managing Regional/Country Labelling documents.
- Knowledge of labelling regulations/requirements in 1 or more regions (EU preferred).
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