As a Regulatory Submissions Manager, you will work with global submission teams and third parties to project manage regulatory major submissions (NDA/MAAs/BLAs, product line extensions, etc.) in priority markets: US, EU, Japan and China from submission through to approval, ensuring that applications and dossiers are prepared to the highest quality standard and in a timely efficient manner.

You will manage submission teams, lead discussion of deliverables and timings, facilitate scenario planning and perform impact analysis. You 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.

Responsibilities:

• 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

Qualifications:

• 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

At GSK we offer a wide range of additional benefits:

• Career at one of the leading global healthcare companies

• Hybrid work ( 2/3 days per week from the office)

• Contract of employment

• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

• Life insurance and pension plan

• Private medical package with additional preventive healthcare services for employees and their eligible

• Sports cards (Multisport)

• Possibilities of development within the role and company’s structure

• Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)

• Supportive community and integration events

• Modern office with creative rooms, fresh fruits every day

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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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