retirement pension plan
PoznańPoznań, Greater Poland
- Offer expired a month ago
- Remote recruitment
- contract of employment
- senior specialist (Senior)
Accountable for delivery of submissions or strategy components for an assigned product in development or marketed product to agreed timeframes and appropriate content independently and confidently.
Works closely with contributing functions to deliver submissions on time, escalate risks associated and proposes risk mitigation.
Plans, communicates and executes activities.
Ensures quality of both own and submission team work and compliance with regulatory guidelines and process as they apply to the role. Provides consultation and solutions being a subject matter expert in processes.
May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities
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.
Acts as mentor and trainer.
May be responsible for the maintenance activities associated with an approved product, including product renewals, site renewals, site registrations, label harmonization, variations, PBRER submissions etc.
Relevant experience (in regulatory affairs, pharmaceutical industry, life sciences research, clinical research, pharmacovigilance)
Bachelor’s or Master's degree in biotechnology, pharmacy, chemistry or other related science or technical field
Experience within Regulatory Affairs in the Drug development and Post Approval environment
Documented track of relevant experience
Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives
Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
Demonstrated project management skills to coordinate submission components
Knowledge of drug development and manufacturing and supply processes.
Knowledge of worldwide CMC regulatory requirements
Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
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.
Ability to build effective working relationships and work in a matrix environment effectively.
What we offer
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.
extra social benefits
one shorter working day
sport and recreation cards
canteen for employees at site (with discounts)
flexible working options available for most positions
Content Delivery in Global Regulatory Affairs at GlaxoSmithKline is a regulatory affairs function which brings together the operation, execution and delivery aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, license maintenance and lifecycle management dossiers. Content Delivery 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.
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 on global submission teams to manage regulatory submissions 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, renewals etc. and for emerging markets. 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.