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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, Country Labelling – Expert
Location: Bengaluru, Karnataka, India
GSK is one of the world’s foremost pharmaceutical and healthcare companies and we are proud to be leading a healthcare revolution. Join us and help empower GSK.
This role will provide YOU with the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following.
- Author and compile Regional/Country PI 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 the 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 (including GRA, Global safety and medical, and Local Operating Companies) to the author, compile and deliver quality labelling documents. May communicate with Regulatory Agencies and third parties on behalf of GRA labelling staff.
- Support other regulatory functions and participate in other projects and activities as needed, such as leading the design and implementation of changes to labelling processes and evaluation of new agency labelling requirements.
- For some roles, may be required to perform translation of labelling text into identified languages.
- Subject Matter Expert in the country/regional labelling content and process for markets with complex labelling requirements:
- provides coaching, mentoring and knowledge sharing within GSK Labelling skill group
- completes quality checks for colleagues’ outputs
- effectively manages interactions with Senior Stakeholders
- takes accountability for the management of labelling deliverables for country/region, including the delivery of high-quality outputs to timelines
- may represent GSK externally.
We are looking for an experienced individual and if you have these skills, we would like to speak to you.
- >7 years of relevant experience (in the pharmaceutical industry, life sciences research or regulatory).
- Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research, pharmacy, safety or regulatory).
- Attention to detail, significant experience of document and database management, excellent organization and time management skills to handle multiple projects for different customers.
- Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.
- Ability to think flexibly in order to meet constantly shifting priorities and timelines.
- Broad understanding of the pharmaceutical industry, drug development environment, development and established product lifecycle maintenance and regulatory processes.
- Knowledge and understanding of product labelling (e.g. through direct exposure to the management of labelling documents/submissions/data; including label authoring).
- Experience of maintenance of labelling documents in multiple countries/regions including knowledge of label document content, process and associated regulatory agency labelling requirements. Experience of more than 1 of the following regions/countries:
- EU PI annexes (including EU CP/MRP/DCP procedures)
- US PIs
- Canadian Monographs
- ROW PIs
- Experience in authoring and/or updating Labelling SOPs, WIs, QRGs by identifying areas for efficiencies in existing Labelling processes
- Proficient with computer software applications
- Familiarity with medical terminology required
- Ability to lead problem-solving and negotiate solutions to complex labelling issues.
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