Senior Regulatory Specialist

Site Name: Egypt - Cairo, Poznan GrunwaldzkaPosted Date: Nov 13 2025At 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. We’re uniting science, technology, and talent to get ahead of disease together.Find out more:Our approach to R&DSenior Regulatory Specialist, Small Molecules Mature Products, CMC, Global Regulatory Affairs – Delivery TeamAre you looking for an opportunity to work on global projects and make a meaningful impact in the pharmaceutical industry?Join the Delivery Team within SMMP at GSK and play a crucial role in global Chemistry, Manufacturing, and Control (CMC) variation projects and Global Supply Chain (GSC) change programs for pharmaceutical products. You’ll be responsible for ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business. You’ll be responsible for preparing technical documentation for global regulatory changes, responding to Regulatory Agency inquiries, and providing expert guidance on CMC variations for Active Pharmaceutical Ingredients (APIs), Intermediates, and Drug Products.In this role, you’ll collaborate with diverse teams across Global Regulatory Organization, Global Supply Chain, Quality Assurance, Contract Manufacturing Organizations, and the Office of the Chief Medical Officer (OCMO) to produce high-quality components for global regulatory dossiers. Additionally, you’ll have the opportunity to mentor and train new team members, contributing to the growth and success of the team.In this role you will…Managing multiple project assignments simultaneously, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Pharma products (working with the CTD Module 3, Quality section of the dossiers).Managing assigned projects by executing agreed dossier strategies, completing data assessments to ensure dossiers are fit for purpose and in compliance with GSK regulatory processes and external requirements for local markets (e.g., 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 colleagues in the Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies in markets worldwide 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.Why you? Basic Qualifications & Skills:We are seeking professionals with the following required skills and qualifications to help us achieve our roles:Bachelor’s or Master’s degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.Relevant experience in regulatory affairs (the pharmaceutical industry), with familiarity in 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, work in a diverse team environment, and build relationships across a large organization.Excellent written and verbal communication skills in English.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.Contact information:You may apply for this position online by selecting the Apply now button.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.