GRL Delegate, Open to flexible working
Content Delivery 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. 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.
Submission coordination (SC) ) is one of the 6 main functional groups Content Delivery . 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 SC Project Lead/GRL Delegate, 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.
- Primary contact for Global Regulatory 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 (US/EU)
- Responsible for the development and implementation of the submission strategy for non-major markets
- Through collaboration with contributing functional lines within and outside of GRA, including LOC, creates and maintains a detailed Submission Plan that captures, key activities and timelines associated with delivery of that content and credible dispatch dates
- Participates and/or Leads submission planning discussions, ensuring team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the inter-dependencies between submission activities and components, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly throughout the submission process.
- 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
- Undertakes Regulatory Matrix Team (RMT) secretariat role
- May be responsible for leadership of relevant submission team or other maintenance activities associated with an approved product, including product renewals, label harmonization, PBRER submissions etc
- Degree in biological or healthcare science qualification
- 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 interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
- 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.
- Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
- Proven ability to think flexibly in order to meet constantly shifting priorities and timelines.
- Fluent English language skills.
- any other languages
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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