Senior Regulatory Specialist, Global Labelling
Site Name: Poznan Grunwaldzka, Warsaw
Posted Date: Feb 27 2020
GlaxoSmithKline is one of the leading global healthcare companies, driven by innovation and scientific developments. Our mission is to improve the quality of life, enabling people to do more, feel better and live longer. We conduct research aimed at improving the quality of life in three basic areas: Pharmaceuticals, Vaccines and Consumer Healthcare. In our activities, we strive to be a responsible partner, building trust-based relations with healthcare system participants, focusing on dialogue and transparent cooperation.
At GSK, we're constantly developing new products and improving our established medicines to improve the quality of human life by enabling people to do more, feel better and live longer. Ensuring these products are correctly prescribed and used is essential, and that's where our labelling team is key. The Labelling team supports our portfolio of medicines by ensuring that the information relating to the safety and efficacy of our products reaches patients and prescribers. This is done through the creation and management of our Company Core Datasheet, which contains information for prescribers and patients.
GSK currently has opportunities in its Global Regulatory Affairs (GRA) - Labelling department, within research and development. These roles are perfectly suited for enthusiastic regulatory professionals with experience or an interest in developing patient and prescriber information and who would like to pursue a career in a global pharmaceutical company. Our Labelling team supports a product during development and throughout its lifecycle, and we are the coordinating authors of Company Core Datasheets for GSK pharmaceutical products.You will liaise with colleagues in clinical, safety and other regulatory functions to ensure that the Prescribing Information, Patient Leaflets and Packaging Components accurately state the Company's medical and scientific position regarding the safe and effective use of a GSK product.
- Providing Local Operating Companies with required documents for national labelling submissions
- Managing multiple requests for Country Local Label Updates and other documents required for national labelling submissions following market specific requirements
- Leading 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.
- 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).
- Experience with PIL and SPC procedures will be a strong asset.
- Fluent communication in Polish and English.
- We offer the opportunity to gain experience in well-known company, to cooperate with international environment where you can have an access to cutting-edge technology and work in friendly atmosphere.
- We provide an attractive remuneration package and benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office), as well as the prospects of a comprehensive professional development.
- Access to newest technologies and solutions.
- Possibilities of development within the role and company's structure.
- GSK corporate culture is based on our values: patient focus, integrity, respect and transparency.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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