Regulatory Manager, Delivery - Licence Maintenance

GSK; Warszawa; Hybrid; PLN 180,000 - 270,000; Full time

Job summary

GSK is seeking a Regulatory Manager, Delivery - Licence Maintenance to lead CMC regulatory strategy across portfolios, overseeing submissions and lifecycle management with cross-functional teams. The role focuses on delivering high-quality CMC outputs, data-driven processes, and risk mitigation in a fast-paced, global environment.

You will drive digital transformation, mentor staff, and ensure adherence to global regulatory requirements while coordinating with internal partners and external

Qualifications

• Bachelor's degree in a scientific or technical field.
• Extensive experience handling complex global CMC submissions and regulatory issues.
• Strong experience in regulatory affairs within pharmaceutical/biotech industry.
• Proven project management and multitasking skills.
• Experience in regulated environments such as pharmaceutical industry research or regulatory roles.
• Strong digital leadership and data-tool fluency including AI applications.

Responsibilities

• Lead the execution of CMC regulatory strategy for licence maintenance across GSK portfolios, including authoring, review and approval of high-quality CMC submissions and variations.
• Ensure efficient delivery and high quality of CMC outputs and that regulatory processes are followed to assure data quality in submissions.
• Independently manage multiple complex CMC projects with planning, tracking and milestone reporting.
• Coordinate cross-functional inputs to produce submission-ready documentation and smooth delivery of CMC projects.
• Prepare, analyze data and author complex CMC regulatory documents to support marketing authorizations and lifecycle activities.
• Understand and apply global regulatory requirements to expedite submissions, reviews and approvals.
• Drive continuous improvement for CMC regulatory processes and lead digital transformation initiatives across CMC Regulatory Affairs.
• Champion adoption of digital tools, AI-supported workflows, and dashboards to improve data stewardship and submission quality.
• Mentor staff and develop subject matter experts in using digital tools and data-driven approaches.
• Maintain networks with key stakeholders and contribute to interactions with worldwide regulatory authorities as needed.
• Track and report team performance using digital dashboards and analytics.

Skills

Digital leadership

Data analytics

Cross-functional collaboration

Project management

Communication

Problem solving

Regulatory strategy

Dossier preparation

Education

Bachelor's degree in a scientific or technical field

Tools

RIM systems

Dashboards

AI applications

Structured data tools

Job description

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

• 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; escal
• 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