Regulatory Manager, Delivery - Licence Maintenance

As Regulatory Manager, Delivery – Licence Maintenance , you will lead the efficient delivery and high quality of CMC (Chemistry, Manufacturing, and Controls) regulatory outputs and licence maintenance activities across GSK’s product portfolios. You will oversee the authoring, review and approval of complex CMC submissions and market-specific requirements, guide cross-functional teams to secure timely regulatory approvals and lifecycle management, and proactively manage risks to achieve optimal regulatory outcomes aligned with GSK’s business objectives. You will also help drive continuous improvement and digital transformation of CMC regulatory processes, strengthening regulatory capabilities and developing subject matter expertise within the team. We value clear communication, strong digital and data skills, practical problem solving, collaboration and a growth mindset. This role offers the opportunity to shape how we deliver CMC regulatory strategy and licence maintenance globally, while developing yourself and others. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • Lead the execution of CMC regulatory strategy for licence maintenance across GSK portfolios by overseeing the authoring, review and approval of high-quality CMC submissions and variations, including market-specific requirements. • Ensure efficient delivery and high quality of CMC outputs and that effective regulatory processes are followed to assess and assure the quality, reliability and consistency of data used in regulatory submissions. • Independently manage multiple complex CMC project assignments simultaneously, including planning, tracking and reporting against key milestones and regulatory timelines. • Coordinate cross-functional inputs from CMC Regulatory Affairs, Global Supply Chain, local operating companies, quality, manufacturing and external partners to produce submission-ready documentation and smooth delivery of CMC projects. • Prepare, analyze data and author complex CMC technical regulatory documents to support marketing authorizations, lifecycle activities and maintenance of registered products. • Understand and apply regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications. • Identify risks associated with submission data and information packages, influence people, systems and processes, and propose alternative approaches; escalate matters that affect corporate or agency policies as appropriate. • Drive continuous improvement for defined and new CMC regulatory processes, including leading or contributing to digital transformation and process-automation initiatives across CMC Regulatory Affairs. • Champion the adoption of digital tools, RIM systems, dashboards, structured data tools and AI-supported workflows to improve CMC submission quality, efficiency and data stewardship practices. • Strengthen CMC regulatory capabilities by mentoring and/or training staff, developing subject matter experts and guiding teams in using digital tools and data-driven approaches. • Maintain appropriate organizational networks and partnerships with key stakeholders (e.g. CMC RA stakeholders, GSC, LOCs, senior leadership) and contribute to interactions with worldwide regulatory authorities as needed. • Track, analyze and report on team performance against key performance indicators using digital dashboards and performance analytics, ensuring digital best practices and accuracy of structured regulatory data across global submissions. • Provide CMC regulatory support and advice to in-licensing, divestment projects and R&D teams, as required. Work arrangement This role is hybrid. You will be expected to work from the office at least two days per week. Basic Qualifications We are seeking professionals with the following required skills and qualifications to help us achieve our go als: • Bachelor’s degree in a scientific or technical field (e.g. pharmacy, chemistry, biochemistry, biotechnology, biology or related life sciences). • Extensive, demonstrable experience handling complex global CMC submissions and regulatory issues, with detailed working knowledge of worldwide CMC regulatory requirements. • Strong experience in regulatory affairs within the pharmaceutical or biotech industry, with expertise in regulatory strategy planning, dossier preparation, technical dossier review and CMC lifecycle management. • Proven project management and multi-tasking skills, with the ability to manage matrix teams and direct multiple projects simultaneously. • Successful track record of working in regulated or quality-critical environments such as pharmaceutical industry research or regulatory roles. • Strong digital leadership skills and high digital fluency, including proficiency with RIM systems, dashboards, structured data tools and AI applications used in CMC regulatory delivery. • Recognized CMC regulatory expertise in one or more subject areas, with highly developed interpersonal, presentation and communication skills. • Experience supervising and training staff and guiding teams in using digital tools and driving a data-driven approach. • Attention to detail, excellent organization and time management skills, with the ability to handle multiple projects for different stakeholders. • Excellent written and verbal communication skills in English. Preferred Qualifications If you have the following characteristics, it would be a plus: • Master’s degree or higher in a relevant scientific discipline (life sciences or related field). • Experience leading or significantly contributing to digital transformation and process-automation initiatives within CMC Regulatory Affairs. • Experience interacting with worldwide regulatory authorities and supporting in-licensing and divestment projects or R&D teams. • Demonstrated ability to influence and negotiate with stakeholders in a variety of settings and to shape the internal/external regulatory environment. • Experience tracking and reporting performance using digital dashboards and performance analytics, with a focus on structured regulatory data quality. • People management experience, including recruitment, coaching, training and development, and serving as a point of escalation for team members and stakeholders (where applicable to the specific posting level). What we offer: • Established job in an international, well-known pharmaceutical company. • Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets. • Opportunity to work within GSK standards and documentation applied globally. • Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus). • Supportive & friendly working environment. We’re looking for someone who thrives in a collaborative environment, is passionate about delivering results, and is eager to make a difference. If this sounds like you, we’d love to hear from you! #LI-GSK #LI- Hybrid Skills Communication, Digital Fluency, Influencing Without Authority, Learning Agility, Pharmaceutical Regulatory Compliance, Problem Solving, Regulatory Strategies, Strategic Leadership Polish Salary Range / Polski przedział wynagrodzenia: PLN 236,250 to PLN 393,750The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits packag