Overview

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

Role Summary

As a Senior Regulatory Specialist, Small Molecules Mature Products, CMC, Global Regulatory Affairs – Delivery Team you’ll be responsible for ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business. You’ll prepare technical documentation for global regulatory changes, respond to Regulatory Agency inquiries, and provide expert guidance on CMC variations for Active Pharmaceutical Ingredients (APIs), Intermediates, and Drug Products.

In this role you will collaborate with diverse teams across Global Regulatory Organization, Global Supply Chain, Quality Assurance, Contract Manufacturing Organizations, and the Office of the Chief Medical Officer to produce high-quality components for global regulatory dossiers, and you will mentor and train new team members.

Responsibilities

• Managing multiple project assignments simultaneously, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for finished products, intermediates and active pharmaceutical ingredients through the CTD Module 3 Quality section.
• Executing agreed dossier strategies, completing data assessments to ensure dossiers are fit for purpose and compliant with GSK regulatory processes and external requirements for local markets (Europe, US, and international countries) and identifying risks associated with submission data and information packages.
• Preparing and coordinating the review and approval of submission‑ready documents.
• Collaborating with Product Owners/Project Managers to provide regulatory support for assigned projects.
• Working with global supply chain, regulatory groups and local operating companies to deliver high‑quality dossiers on time.
• Building and maintaining strong relationships with internal and external stakeholders.
• Monitoring regulatory intelligence and proactively acting on identified changes to regulatory requirements.
• Identifying improvement opportunities for CMC regulatory processes, policies and systems.

Qualifications

• Bachelor’s or Master’s degree in biotechnology, chemical technology, pharmacy, chemistry or another related science or technical field.
• Relevant experience in regulatory affairs within the pharmaceutical industry, familiarity with post‑approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).
• Understanding of the pharmaceutical industry, drug development environment and regulatory processes.
• Thorough understanding of change management processes and regulatory requirements.
• Attention to detail with an emphasis on accuracy and completeness.
• Ability to handle multiple tasks, meet shifting priorities and schedule work to meet business needs.
• Flexible and analytical thinking to independently provide solutions to issues.
• Excellent interpersonal skills, including the ability to communicate clearly and effectively and build relationships across a large organization.
• Excellent written and verbal communication skills in English.

Working arrangement

This role is based in Poland and is offered as a hybrid position. You will be expected to attend the office regularly for team collaboration and stakeholder meetings.

What we offer

• Performance with Choice – flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours.
• Established job in an international, well‑known pharmaceutical company.
• Opportunity to work in a professional team playing a 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, Sports and recreation cards, Recreation allowance, annual bonus).
• Supportive & friendly working environment.

Salary and Benefits

The annual base salary in Poland for new hires in this position ranges from PLN 131,250 to PLN 218,750 gross, with potential eligibility for a bonus and awards. All statutory benefits will be maintained in accordance with Polish law.

Equal Employment Opportunity

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity and sexual orientation), parental status, national origin, age, disability, genetic information, family medical history, military service or any basis prohibited under federal, state or local law.

Invest in GSK

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.