Regulatory Global Submission Manager (New Chemical Entities, New Biological Entities)
- Warsaw, Poland
Site Name: Warsaw, Poznan Grunwaldzka
Posted Date: Aug 31 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, 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. They develop and manage detailed project plans for major submissions in key markets in which GSK does business and ensure applications and dossiers are prepared in compliance with Regulatory Authority regulations and guidances and with GSK SOPs and working practices. As a Regulatory Global Submission Manager, you will work with global submission teams and third parties to project manage regulatory submissions (including global NCE/NBE 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 manage submission teams, lead discussion of deliverables and timings, facilitate scenario planning and perform impact analysis. He/she will utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated GSK systems and planning software to ensure teams meet aggressive target submission dates and proactively focus on critical path acceleration, efficient hand-offs, and reduction in "rework" to avoid costly 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.
- Accountable to Global Regulatory Lead and Global Regulatory Affairs staff for the project management of major submissions.
- Provides guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets.
- Through collaboration with contributing functional lines, creates and maintains a Global Submission Plan that captures detailed list of dossier content, key activities and timelines associated with delivery of that content, target governance board review time frames, and credible dispatch and Health Authority approval dates for key markets.
- To ensure GSK's competitiveness in drug development, work with teams to identify ways to optimize and accelerate bringing products in our late-stage pipeline to market, focusing on key activities and processes from last subject last visit (LSLV) to submission and approval.
- 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.
- Performs scenario planning when multiple regulatory strategies are being considered.
- Provides various visuals, reports, scorecards, etc. to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders.
- Works closely with data generating groups to monitor progress and ensure team is on-track to delivery according to plan. When potential issues and delays are identified, works to expeditiously find solutions in order to keep the team progressing toward the target submission time frame.
- Responsible for understanding, adhering to, and advising others on global Regulatory Authority regulations and guidance associated with electronic submissions, which differ across regions and Regulatory Authorities.
- Facilitate post-submission after action reviews (AARs) to identify key learnings and best practices which are then used to refine and improve GSK submission processes.
- Education - preferred degree in a biological, health care, or life science discipline.
- Project management experience in the pharmaceutical industry, preferred in regulatory environment.
- Understanding of the pharmaceutical drug and vaccine development environment, and R&D processes and objectives.
- General knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV.
- Proficiency with Microsoft Project and/or other project management tools will be an asset.
- Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
- Effectively lead multidisciplinary team meetings and drive discussions regarding submission content, timelines, resource allocation, risk management, etc.
- Ability to proactively identify and mitigate risks and potential bottlenecks and effectively interact with stakeholders to ensure transparency of submission progress/status.
- Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
- Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
- Important and interesting job in one of the leading global healthcare companies.
- An opportunity to play a key role in bringing new medicines and vaccines to patients.
- A position that liaises with various functional areas and culminates years of work into a marketing application that is submitted around the world.
- Possibility to work with engaged and enthusiastic people from various locations.
- Training on the newest project portfolio management software solutions and content management platforms.
- 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.
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