Director, Regulatory Platform Innovation

Director, Regulatory Platform Innovation Job Purpose The Director, Regulatory Platform Innovation, should possess a digital mindset, understand the Regulatory Operations landscape, and have a successful track record of delivering Technology and Business Transformation initiatives, using various methodologies, in a fast-paced environment. This pivotal role requires strong leadership, delivery expertise, technological acumen, and deep regulatory knowledge within the pharmaceutical industry. The successful candidate will lead the scoping, integration, and delivery of innovative regulatory programs of work, leveraging emerging technologies to enhance regulatory processes and advancement. This role is crucial for driving strategic innovation that aligns with GSK's mission and regulatory requirements. Key Responsibilities: Leadership: Lead the planning, execution, and delivery of regulatory technology and innovation programs, ensuring projects/programmes are designed to deliver maximum value and are aligned with strategic objectives and regulatory standards. Project/programme Planning: Oversee the progress of projects/programmes with respect to time, scope, budget, risk, quality, and compliance, holding leaders and teams to account to ensure execution in accordance with the plan. Develop realistic roadmaps/plans with agreed deliverables, ensuring alignment across systems, data, process, and people. Establish key metrics and KPIs for evaluation of project/programme performance and conduct collaborative retrospectives as needed. Identify areas of improvement and implement corrective actions accordingly. Ensure a user-centric, iterative delivery approach based on business value, with tangible measurable success metrics/KPIs. Manage budgets, forecasts, and resource allocation to optimise efficiency and cost effectiveness. Communicate project/programme status, updates, and outcomes to stakeholders at various levels of the organization. Prepare and present progress reports, executive summaries, and other documentation as required. Governance and Risk Management: Establish and facilitate project governance frameworks to ensure alignment with goals and timelines, drive decision making, and implement risk management strategies and contingency plans. Cross-Functional/Vendor Collaboration: Collaborate with cross-functional teams, including (but not limited to) Tech, R&D, Quality Assurance, and external partners, to define project/programme scope, objectives, and deliverables. If applicable, lead the engagement and performance of third-party vendors, inc. relationship management, negotiation of contracts, compliance with procurement/legal teams, influencing of vendor roadmaps and dependencies, and negotiation of budgets. Facilitate impact assessments and partner with Process, Data and Business Change teams as needed to ensure seamless delivery into the business with minimal disruption to end users and business operations. Team Leadership: Provide leadership and guidance to project teams, promoting collaboration and a shared commitment to achieving project goals. Mentor and support team members in their professional development. Provide leadership and guidance (and line management where applicable) to more junior staff, Product managers/owners and teams to drive successful project delivery. Where required, mentor and develop staff to build a high-performing team. Compliance Assurance: Ensure compliance with relevant GSK regulations, policies, and standards. Partner with GSK Quality teams to ensure compliance. If needed, represent Regulatory Platform Innovation team in inspections/audits/councils. Stay updated on regulatory changes and ensure projects adhere to new regulations. Continuous Improvement: Stay informed about industry trends, regulatory developments, emerging technologies (e.g. AI, automation, machine learning) and advanced digital tools. Actively seek out areas of improvement, driving forward innovation. Present recommendations and investment proposals to senior management and stakeholders, clearly articulating the strategic value and expected outcomes. Foster a culture of continuous improvement by actively and regularly engaging with user communities, seeking feedback and improvement opportunities. Basic Qualifications: Bachelor degree in scientific or technical discipline. Experience of delivering large scale, complex Technology and Business Transformation programs (System, Data, Process, People), working with different methodologies as needed. Experience in defining realistic and achievable plans to manage multiple programs of work with an awareness of prioritization and impact. Experience in building, mentoring, and managing high-performing teams. Knowledge and experience of project management tools (E.g. Smartsheet, MS Project). Holds Project Management or Scaled Agile certifications (e.g., PRINCE, PO/PM) Knowledge and experience of regulatory systems including the validation requirements associated with GxP systems. Knowledge and experience of JIRA and effective requirements decomposition (Epic -> Feature -> User Story -> Task) Preferred Qualifications: PM and/or Agile qualifications Service/customer-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment. Possesses a digital mindset embracing technology/tools as a catalyst for innovation, efficiency, and growth. Focuses on value - Identifies and prioritizes initiatives based on value to the company. Has strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way. Demonstrated ability to think flexibly and innovatively to meet constantly shifting priorities and timelines. Proven ability to take an organized and methodical approach to problem solving/trouble shooting. Excellent attention to detail and commitment to deliver high quality output, even under pressure. #LI-GSK* 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 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. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. 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For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it 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. Find out more on our career site.