Regulatory Submission Lead

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About the role

You will lead planning, compilation and delivery of regulatory submission dossiers for lifecycle activities. You will coordinate with global submission teams, clinical, CMC (Chemistry, Manufacturing and Controls), quality, publishing and local regulatory partners. We value organised, collaborative people who communicate clearly and focus on practical solutions. This role offers visible impact on patient access, clear growth opportunities, and aligns with GSK’s mission of uniting science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: - Plan, compile and deliver high-quality electronic and paper regulatory dossiers within agreed timelines. - Coordinate cross-functional inputs from clinical, CMC, quality, safety and commercial colleagues to complete submissions. - Build, validate and quality-check electronic submission packages and resolve technical validation issues. - Maintain submission trackers, version control and milestone plans to ensure transparency and audit readiness. - Prepare responses to regulatory authority questions and support regulatory meetings when required. - Identify and implement process improvements, coach colleagues and share best practice. Why You? Work arrangement This role is hybrid. You will work on-site 2–3 days per week and remotely for the remaining days, as agreed with your manager. Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: -Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory affairs or a related discipline, or equivalent experience. - Minimum 3 years’ experience in regulatory affairs, submission management, publishing or lifecycle maintenance in the pharmaceutical or clinical research environment. - Practical experience compiling regulatory dossiers and managing submission timelines for investigational or marketed activities. - Experience preparing electronic submissions and familiarity with eCTD principles or equivalent electronic submission practices. - Strong written and verbal communication skills in English; able to present clear updates to stakeholders. - Strong organisational skills, attention to detail and ability to manage competing priorities under deadlines. Preferred Qualification If you have the following characteristics, it would be a plus: - Experience with regulatory content or information management systems such as Veeva Vault or similar platforms. - Experience with CMC content, Module 1 preparation or local language submission requirements. - Experience supporting regulatory authority interactions and preparing authority responses. - Practical knowledge of market regulatory requirements. - Experience working in a global, matrix environment and coordinating third-party service providers. - Acting as single point of contact for submissions. What we value in you You make evidence-based decisions and raise issues early. You balance pace with rigour and focus on quality. You build strong working relationships and share learning. You bring a growth mindset and a willingness to coach others. You will help improve patient access through regulatory excellence. 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’

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