Hybrid CMC Regulatory Delivery Lead

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

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