Regulatory Project Lead (for new R&D products)
- Luboń, Poland
Site Name: Warsaw, Poznan Grunwaldzka
Posted Date: Aug 18 2020
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, licence 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 (NCE GD) is one of the four main functional groups within Global Regulatory Platform and Delivery (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 Project Lead, you will work closely with the Global Regulatory Lead (GRL) and local operating company regulatory contacts to confirm requirements, deliverables and agree timelines and plan/implement delivery strategy for markets globally in which GSK does business. You will ensure dossiers are prepared in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices. You will also plan and ensure delivery of life cycle activities for EU Centralised products (for example variations, periodic benefit risk evaluation reports (PBRER), Paediatric Investigation Plans (PIP) etc).
The role also entails mentoring/coaching submission coordinators working on the Project Lead's assigned products and reviewing their work output to ensure right first time submissions. The ideal candidate should have good project management, organisational, collaborative working and communication skills plus a good knowledge of global regulatory submission requirements.
- Accountable to GRL lead for delivery of submissions or strategy components for an assigned product in development or marketed product; planning own and submission team activities to ensure delivery to agreed timeframes and appropriate content.
- Responsible for the implementation of the submission strategy for major markets
- Responsible for the development and implementation of the submission strategy for non-major markets
- Ensures quality of both own and submission team's 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 part of the Regulatory Matrix Team for the given product and accountable for leadership of relevant submission team.
- May be responsible for the maintenance activities associated with an approved product, including product renewals, label harmonization, PBRER submissions etc
- Degree in biological, health care, or life science discipline
- Global Regulatory submission experience - knowledge of regulatory agency guidelines and expectations for submissions.
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines and managing multiple submissions simultaneously.
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
- Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
- Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
- Proven ability to think flexibly in order to meet constantly shifting priorities and timelines.
- Fluent English language skills.
- 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 GSK values: patient focus, integrity, respect and transparency.
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