Senior Regulatory Specialist

**Site Name**: Egypt - Cairo
**Posted Date**: Jan 27 2026

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. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: : Our approach to R&D

Senior Regulatory Specialist

You will be responsible for ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business. You will 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 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 (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.

**Responsibilities**:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

- 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?

Our requirements:

- 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.

Work arrangement

This role is hybrid, based in Egypt with regular attendance at the Cairo office 2-3 times per week.

How to apply

Why GSK?

What we offer

You will join an organisation that aims to make a real difference to patients. We invest in learning and development to help you grow. You will work with people who value inclusion and diverse perspectives. If you want to build a meaningful career in oncology GSK and help shape better outcomes for patients, we encourage you to apply.

**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 ah