Site Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, UK - London - Brentford, USA - North Carolina - Research Triangle Park Posted Date: Mar 1 2022 Are you energized by the challenge of shaping and accelerating the scientific expertise of a biology program? If so, this Biology Manager opportunity could be an exciting opportunity to consider. As Regulatory Global Submission Manager, you will work with global submission teams and third parties to project manage regulatory submissions (primarily global NCE/NBE marketing applications and product line extensions) 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 This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following. Accountable to Global Regulatory Lead and Global Regulatory Affairs staff for the project management of major submissions. Acts as subject matter expert to provide 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 timeframes, 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 interdependencies 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 timeframe. 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. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environment Project management experience in the pharmaceutical industry or in a regulatory environment. Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. General knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV Familiarity with Microsoft Project and/or other project management tools Excellent written and verbal communication skills and ability to present information in a clear and concise manner Preferred Qualifications: If you have the following characteristics, it would be a plus: Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment. Proven ability to think flexibly in order to meet constantly shifting priorities and timelines. Demonstrated leadership and negotiation skills with ability to persuade and influence others (regardless of level) in achieving team objectives. 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. Proven effectiveness leading multidisciplinary teams and driving discussion 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. Sense of urgency and ability to work well in high pressure / high stress situations Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK #VaccinesRD If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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