- Grunwaldzka 189, 60-322 Poznań, PolskaPoznań, wielkopolskie
- Ogłoszenie wygasło 16 dni temu
- Umowa o pracę
- Pełny etat
- Kierownik / Koordynator
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, labelling outputs, license maintenance and lifecycle management dossiers and regulatory information management. GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).
Step up to the new challenge and take the lead in a diverse international regulatory environment. Bring a real value to our Patients worldwide by having a high level of impact on delivery of the early and late-stage pipeline.
New Chemical Entity Global Delivery is one of the four main functional groups within GRPD. This group project manages and delivers complex high priority major submissions to our Local Operating Companies and to Regulatory Authorities around the world.
As a Submission Coordinator, you will work closely with project lead, global regulatory lead and local operating companies in regards to requirements, deliverables and timelines for EU as well as emerging market submissions in which GSK does business and ensure applications and dossiers are prepared in compliance with Regulatory Authority regulations and guidance’s and with GSK SOPs and working practices.
The job holder will work with global submission teams to manage regulatory submissions (including global New Chemical Entity (NCE) marketing applications, product line extensions, Investigational New Drug applications, etc.) from submission through to approval, ensuring that applications and dossiers are prepared to the highest quality standard and in a timely efficient manner. The job holder will utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated GSK systems and ensure teams meet with target submission dates. Supports project lead with requesting the administrative requirements for different countries, efficient hand-offs to publishing team for all modules and life cycle maintenance activities for EU product license like PBRER, PIP etc. Proactively work with team and try reduce “rework” to avoid time delays, while at the same time ensuring all necessary quality reviews and approvals are achieved, allowing GSK to continue producing applications to the highest quality standard.
Regulatory Submission Coordinator (for R&D new products)Numer ref.: 254656
- Accountable to Project Lead and Global regulatory leads )for delivery of assigned submissions to agreed timeframes and appropriate content
- Ensures quality of both own and submission team work and compliance with regulatory guidelines and process as they apply to the role.
- Works with staff from other functions, and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidances, researching topics and resolving issues.
- May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
- May be responsible for the maintenance activities associated with an approved product, including product renewals, label harmonization, PBRER submissions etc
- Plans, communicates and executes activities with minimal input from manager
- Relevant experience (in regulatory affairs, pharmaceutical industry, clinical research)
- Bachelor’s or Master's degree in biotechnology, pharmacy, chemistry or other related science or technical field
- Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
- Excellent written and verbal communication skills in English and Polish, 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
- Knowledge of global regulatory agency guidelines and requirements including CMC and market specific requirements.
- Knowledge of drug development and relevant experience within Regulatory Affairs.
- Important and interesting job in one of the leading global healthcare companies.
- Possibility to work with engaged and enthusiastic people from various locations.
- Access to newest technologies and solutions.
- Possibilities of development within the role and company’s structure.
- Benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office).
- Corporate culture based on our values: patient focus, integrity, respect and transparency.