Senior Regulatory Specialist, Global Labelling
Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labeling outputs, license maintenance and lifecycle management dossiers and regulatory data management. GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).
The GRA Labelling team are creating new roles in the GRPD Poznan team. The purpose for the role will be timely maintenance of Global and regional/country Product Information (PI), including information for healthcare professionals and patients as well as providing expertise and support to Local Operating Companies with respect to Global Product Information processes and responses to Regulatory Agency questions about Product Information.
• Leading or participating in the development of the Company Core Datasheet (Global Product Information) for new medicines or product line extensions.
• Maintenance of country/regional labelling in compliance with GlaxoSmithKline labelling processes and external requirements for local markets e.g. Europe (for Centralised, Mutual Recognition and Decentralised procedure submissions) US and International countries.
• Managing core and local prescribing/patient information throughout the product lifecycle.
• Working with colleagues in GSK Local Operating Companies in markets worldwide to ensure the company core datasheet is accurately reflected in local prescribing/patient information.
• Authoring responses to prescribing/patient information questions from Regulatory Authorities.
• 2-5 years relevant experience ((in pharmaceutical industry, life sciences research, regulatory or medical affairs, clinical research, pharmacovigilance or alternatively therapeutic area experience from research).
• Successfully performed within a regulated or quality-critical environment (such as pharmaceutical industry research or regulatory).
• Attention to detail, excellent organization and time management skills.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
• Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues.
• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
• Understanding of product information/labelling (e.g. direct or indirect management of labelling documents and submissions).
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.
Closing date for application: 30/07/2018
Please note that interviews for these roles will commence from ASAP, due to the short recruitment period we would appreciate your flexibility in attending interviews asap.
You may apply for this position online by selecting the Apply now button.
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